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IHMA & IHMF: Sister Organizations Translating
        Science into Medical Practice and Public Policy to
         Create Healthcare Solutions for the 21st Century

Using Aerospace Medicine in 21st Century Medical Practice

                       Presentation to:
Independent Football Veterans Conference
                       Las Vegas, Nevada
                         April 21, 2012


  Practical Hyperbaric Medicine for Athletes &
               Recovering Athletes
  Using the Principles of Translational Medicine
                  William A. Duncan, Ph.D.
             Vice President for Government Affairs, IHMA
                 Vice President of Development, IHMF
Football is Dangerous!



“We Might
Have to Do
Away with
 Football”
 Statement from a U.S. Congress member
Fact: Many Sports are Prone to Head Injury
          Do we do away with all of them?
•   Soccer
•   Cheerleading
•   Snow Boarding
•   Skiing
•   Rugby
•   Horse Sports
•   Prize Fighting
•   Rodeo
America’s Heroes Answered Our Nations Call
Military Medicine Reports 40% have been exposed to blast and RAND reports
         Over 1/3rd have Suffered Traumatic Brain Injury and/or PTSD
•   Brian Schiefer is an American Hero
•   Joint Terminal Attack Controller (JTAC)
•   3.5 years to train
•   One in 1,000 USAF Personnel Qualify
•   Worth $5 million
•   After 3 Deployments of over 20 months to Iraq and
    Afghanistan, Brian was injured during a pre-deployment
    training exercise at Fort Irwin, CA that left him paralyzed.
•   He was not evaluated for a brain injury until almost a year
    and a half after his accident even though incurring a skull
    fracture to his temporal lobe which resulted in a loss of
    consciousness.
•   He was treated with the NBIRR-01 protocol, 80 treatments,
    and his recovery has permitted him to regain his life and be
    productive again.
•   Brian joins many active duty war veterans who were able
    to continue their careers in the military, and those who           Brian Schiefer, USAF.
    have returned to civilian life with great improvements in Many millions of tax dollars have
    their quality of life and restored productivity.             been saved because of
•   See Brian’s Story at www.HyperbaricMedicalFoundation.org   hyperbaric oxygen therapy!
Marine: Battle of Fallujah
           Never Unconscious
      Prior to 40 HBOT Treatments




Source: Patient’s Family
Football Player’s Brain: Avg 200
     Concussions Before NFL Play
NFL Player & Combat Injuries
Similar                                     Images of NFL Player Before & After
•   The Damage from Multiple
    Concussions in Sports is very similar
                                                                         Before
    to the Marine from Fallujah
                                                                         HBOT
•   Published Reports Estimate the
    Average NFL Player has sustained 200
    concussions before starting to play
    professional football!
•   This indicates a tremendous
    biological reserve capacity in these
    professional athletes brains!
•   These athletes likely have “Genius                                  After
    Level” Reserve Capacity!                                            HBOT
•   (Discussion on Reserve Capacity: The
    Oxygen Revolution-Harch-2010)
All of These Situations Can Lead to
     an Untreated Brain Insult
•   Plus Falls               A 9 Mile Per Hour
                               Motor Vehicle
•   Motor Vehicle Accidents Collision Can Leave
•   Victims of Crime         a Residual Brain
•                                   Injury
    Domestic Violence            (UCLA Research)
Results of Untreated Brain Insults
• 50% Future Lifetime                • Incarceration
  Loss of Income                     • Anger Issues (including
• 45% Unemployed two                   Road Rage)
  (2) years post injury              • Sleep Disorders
• Early Retirement                   • Depression
• Early Onset Dementia               • Compulsive Gambling
• Homelessness                       • Dysfunctional Family
• Substance Abuse                      Life
• Costs Society $60,000              • Suicide
  Per Year!
    One [Brain Injured Person] effects 40 others around them!
                   Alcoholics Anonymous Big Book
“Recovery” does not mean
“healed without residual effect”
Acute Injury? Minutes Matter

                               71.3 m
                         12.8 min
                          5.2 min
Current Reimbursed Largely Ineffective
         Drug Treatments (Symptom
                Management)
    Suicides now exceed losses from combat casualties!
    There is no drug currently approved by the           •
                                                         •
                                                             Psychiatry (Con’t)
                                                             Antidepressents (All Black Label Warning Suicide)
    FDA to treat TBI. The only drugs approved for        •   Celexa
    PTSD are Zoloft and Paxil. All other treatment       •   Lexapro
    with drugs for these conditions is off-label and     •   Prozac
                                                                              All in Red carry a black label
    intended to treat symptoms. In fact, a significant   •   Luvox            warning for suicidality in
    percentage of psychiatric medications are            •   *Paxil
                                                                              those under age 25!
    prescribed off-label. Further, the use of            •   *Zoloft
                                                         •   Cymbalta
    antipsychotics in these patients is often as a       •                    The Veteran Suicide Rate is
                                                             Effexor
    chemical restraint.                                  •   Wellbutrin
                                                         •   Remeron
                                                                              120 per week!           (CDC Numbers)
    The following list of drugs are FDA approved for     •   Desyrel
    psychiatric and neurologic disorders. The great                           All in Red Fail to beat
    majority of these drugs have been and are            •   Antimanic
                                                                              Placebo yet Millions Spent!
    currently prescribed by DoD Medicine off-label for   •   Tegretol
    TBI/PTSD in the service members Dr. Harch has        •   Lamictal         (Journal of Clinical Psychiatry, Nov 29, 2011)
    treated with HBOT 1.5 in New Orleans.                •   Eskalith
                                                         •   Topamax
    Neurology:            Psychiatry                     •   Depakote
     Alzheimer's          Anti-anxiety                   •
•   Ebixa                 Lectopam                       •   Antipsychotics          August 2, 2011: $717 million
•   Klonopin              Tranxene
                                                         •   Clozaril             spent by VA on Drug that does not
                                                         •   Zyprexa
•   Neurontin             Valium                         •   Seroquel
                                                                                               work!!!
•   Lyrica                                               •   Risperdal             DoD Could have repaired 176,000
                                                         •   Geodon                       themselves w/ O2!
•   Topamax                                              •   Abilify                “Antipsychotic Doesn’t Ease Veterans’
•   Dalmane
                                                             *FDA Approved for PTSD Post-Traumatic Stress, JAMA Published
•   Symmetrel                                                                       Study Finds” - NYTimes.com
Non-Healing Wound of the Foot
         Diabetic Foot Ulcer: This Wagner Grade III was present for one
                year and unresponsive to conventional therapy.




1 Day Prior to Scheduled Amputation                          26 HBOT Treatments

                                      Hyperbaric Oxygenation prevents
                                      75% of amputations in diabetic patients.
                                      Therapy approved by CMS for Medicare
                                       upon application by IHMA to CMS for
                                      coverage, 2003.
                                         These photographs are the property of Kenneth P. Stoller, MD, FAAP
                                         Permission given by Dr. Stoller to the IHMA to publish on this CD (2004)


                                                  Copyright retained: Kenneth Stoller, M.D.,
       50 HBOT Treatments                                       2010 & IHMA
Solution?
Biologically Repair the Brain




  Case Published in: Cases Report June 2009 http://casesjournal.com/casesjournal/rt/suppFiles/6538/31370
Brain Insults often Result in a 50%
       Decrease In Brain Metabolism
     HBOT Restores Brain Metabolism




Case Published in: Cases Report June 2009 http://casesjournal.com/casesjournal/rt/suppFiles/6538/31370
Solution: It’s Just Oxygen!
         Oxygen is being used to repair an injury caused by a lack of oxygen!
•   O2 used in 5,769+ cellular processes                  Pressure causes
•   HBOT activates 8,101 Genes!                               oxygen to
     – Down Regulates Inflammation Processes
     – Up Regulates Growth & Repair Processes              saturate tissues
     – Normobaric O2 does not!                               at 7x to 12x
•   Simple: Lack of oxygen is bad                         normal breathing.
•   We know how it works
     –   Acutely stops swelling/reperfusion injury
     –   Restarts stunned cellular metabolism
     –   Regrows Blood Vessels
     –   Activates Stem Cells 8x Normal
•   No wound can heal without oxygen
     – Wounds that have not healed do
     – Wounds heal 50% faster with less scar tissue
     – Broken bones 30% faster & 30% stronger
•   Placebos have to have the potential of                HBOT is FDA-approved & available &
    being inert. Saturating injured tissue with oxygen   On-Label for neurological conditions &
    has never been shown to have a placebo effect!               non-healing wounds!
Results Speak for Themselves
•   NBIRR-01 Begins Enrolling Patients March 2010. Preliminary Results from multi-site study support
    Harch’s Findings.
•   LSU Pilot Published in the Journal of Neurotrauma, J Neurotrauma. 2011 Oct 25. A Phase I Study of Low
    Pressure Hyperbaric Oxygen Therapy for Blast-Induced Post Concussion Syndrome and Post Traumatic
    Stress Disorder PMID: 22026588
     – Subjects as a group showed significant improvements on most measures of intelligence, function
         and quality of life
     – All subjects received 1/2 the clinically recommended protocol being used in NBIRR-01 (
         NCT01105962)
     – Nearly 15 point IQ Increase (average) (Difference between a high school dropout & a college
         graduate)(14.8 P<.001 )
     – Post-Concussion Syndrome (PCS): 39% Reduction in PCS symptoms (p=0.0002); 87% substantial
         headache reduction
     – 30% Improvement in PTSD (20 points of a 62 point scale; a patient must score 50 on to have PTSD
         “diagnosis”)
     – 51% Reduction in Depression Indices with Large Reduction in Suicide Ideation(p=0.0002)
     – 64% had a reduced need for psychoactive or narcotic prescription medications
     – 92% reported sustained improvement 6 months post treatment
     – Functional Improvements: Cognitive 39% (p=0.002); Physical 45% (p<0.001); Emotional 96%
         (p<0.001)
            • Significant Reduction in Anger Issues!
     – Placebo Effect Ruled Out! Results too great to be placebo effect and neurological imaging is
         inconsistent with a placebo effect
HOPS: Translating Known Science
        into Medical Practice
• Athletes (Professional & Amateur) have four basic problems
   – Acute Untreated Brain Insults
   – Chronic Untreated Brain Insults (prior injuries)
   – Blunt Trauma Injury & pulled Tendons
   – Need for Recovery After Strenuous Training
   – Injuries that may require surgical intervention
• IHMF’s Hospital Outcomes & Profit System (HOPS), creates a
  system that enables acute delivery of consistent HBOT
  protocols for all indications.

   Hyperbaric Medical Protocols Currently
      Exist for ALL of these Challenges
As A Professional Football Player
              Step 1
• Step 1: Reset the Brain’s Reserve Capacity & Function
   – 80 HBOT 1.5 NBIRR-01 Protocol Treatments & Evaluate
   – Reserve Capacity Detailed in Harch’s Oxygen Revolution,
     2nd Edition, pages 120-128
   – NFL Players have Genius Level Reserve Capacity
      • Reportedly NFL players have sustained, on average 200
         concussions BEFORE they start playing pro ball.
      • Top 1% of High School to College Ball, to 1% of College
         Ball to NFL
      • Olympic Level Athletes
• Recover Reaction Time, IQ, Executive Function, Memory &
  Processing Speed
As A Professional Football Player
              Step 2
• Receive Acute HBOT Treatment for any NEW
  Concussions Using the IHMF’s Acute Brain
  Insult Protocol (NBIRR-11)
• Receive Acute “Sports Injury or Falls” HBOT
  Treatment for Concussions (NBIRR-11), Blunt Trauma
  (ACTS-08) or Spinal Cord (Acts-11) or Fracture Protocol
  (ACTS-09) (Combined as ACTS-05 & ACTS-01 Respectively)

• Have Pre-Post Surgery (ACTS-06) for any
  surgical interventions or repairs
Returning Athletes to Competition
                 • U.S. Olympic Team
                   – Treated at San Diego
                     IHMF-NBIRR Site
                   – Sports Injuries
                   – Concussions
                   – Summer & Winter Sports
                 • U.S. Navy SEALs &
                   SOCOM Members
                   – Treated for Fractures
                   – Treated for Knee
                     Replacement
                   – Treated for TBI and PTSD
Fractures
  • Air Force Research
    Demonstrated that Fractures
    heal 30% faster and 30%
    stronger when Hyperbaric
    Oxygen is used.
  • Shorter back to work time
  • Stronger Fusion
  • Cost Effective through
    reduced down time
  The effect of hyperbaric oxygen on fracture healing in rabbits, completed 2003. J Wright
Is Hyperbaric Medicine Safe?
Source: “HBOT for TBI” Consensus Conference, December 2008

• Treatment involves          • The DoD White Paper
  simply breathing pure          stated: “side effects are
  oxygen under pressure          uncommon and severe or
                                 permanent complications
  (often while sleeping or
                                 are rare…” (White Paper for
  watching TV).                  the HBOT in TBI Consensus Paper,
• Ten thousand plus              12/08)
                              • The DoD After Action
  similar treatments are
                                Report stated: “safety of
  given every day at            the treatment is not an
  1,200+ locations              issue.” (After Action Report HBOT in TBI
  nationwide for other           Consensus Conference, Defense Centers of
                                 Excellence, 16 Dec 2008)
  indications.
Examples: HBOT is Synergistic
        with Other Treatments
•   Drug Protocols                    •   Cognitive Rehabilitation
     – Patients in the LSU Study           – Treatment Cannot Begin
       were on no medication or               until a Patient can Sleep
       less medication                        Through the Night
     – Medication was now more             – HBOT Repairs Sleep Cycles
       effective at controlling               and most Patients can begin
       symptoms                               sleeping at 10 HBOT
•   Nutritional Programs                      Treatments
     – NBIRR Nutritional Program           – When Brain Tissue is
       reduced Aberrant Violent               Recovered, it is somewhat
       Behavior in Felons in 30 RCT           disorganized!
       Studies by 39-41%              •   Acupuncture
     – Harch did not use NBIRR        •   Bio-Feedback
       supplement in his study        •   Counseling & Coping Skills
24
Image Courtesy of Dr.
Retired NFL Player: Age 58
                             Pre-Post HBOT 1.5
               4+ NFL Players now treated with similar results




Source: MicroCog Assessment-- Independent Evaluation by Amen Clinic. NBIRR Subject Courtesy of Dr. Stoller
Example of TBI impact assessment in NFL Player
                                                       Enlarged Fiber Tract showing
  • NFL football player with                           fibers from concussive event


    concussion
  • Loss of about 2% of the
    fiber tracts in the region of
    the corpus callosum.
         Courtesy Dr. Walter Schneider,
             U Pittsburgh [fMRI photo]

Area of Tissue change   Fibers passing through areas
Severe TBI Patient: Whole Brain CT Perfusion Pre & Post HBOT




    Pre HBOT – 10/16/09                Post HBOT – 10/28/09
Images Courtesy of Dr. Germin, Las Vegas
IHMF’s National Brain Injury Rescue and Rehabilitation Project
    NBIRR-01: Mild-Moderate TBI Ages 18-65

• 1,000 patients with mTBI    • All participants have
  and/or PTSD ANY CAUSE         improved
• 17+ centers                 • Most improved in every
• All receive HBOT              measure
• Early results encouraging   • Most improved
• 35 participants in treatment  substantially
  (Mar 2011)                  • No participants worsened
                              • Results are durable
Many are U.S. War Veterans who have had to be treated
      “for free” by the clinics as charity cases!
 NBIRR Study, see: http://www.clinicaltrials.gov/ct2/show/NCT01105962
John Eisenberg Treatment Registry (JETR) Provides Structure for
                           the NBIRR-01 HBOT 1.5 TBI/PTSD Study &
                Is a Clinical Research Platform for Translational Medicine Powered by CareVector®
•   Platform Follows FDA-Devices
    Methodology for Medical Evidence
     –
                                                                       IRB Workflow
         Supports Multi-Site World-Wide Studies
     –   Online Data Entry Forms
     –   Security Roles protect patient privacy
•   Site Records all DoD ANAM Test Scores                   Identify
    & all Other Diagnostics                                 Patient
•                                                                      Screening &
    Web-based Reporting & Analysis                                Capture Demographics
     –   3rd Party Payer/Policy Auditing as Requested
     –   Analysis Tools Available to Auditors                                             Pre-Rx Exam
     –   Permits CMS “Coverage with Evidence” Rules                                        & Testing
•   All Patients get Real Treatment No Placebo!
•   NO BARRIER To 3rd Party Reimbursement                                                                  Treatments
     –                                                                                                     (40 HBOT)
         Normally “Study” treatments are not
         reimbursable because of placebo (no)                Post-Rx Exam
         treatment provided. This study design permits         & Testing
         3rd party payers to pay for treatment and have
         it tracked for analysis and rapid proofing.                         Analysis &
     –   Willing to only be paid when the treatment                          Reporting
         works under the rules of HR 396, TBI
         Treatment Act                                                                          Patient
•   Evidence-based Medicine Rules & Bayesian                                                   Follow-up
    Analysis Permits
     –   Rapid Publication & Potential FDA Marketing      JETR is a Tool Permitting Practitioners to Proof
         Approval                                         Off-Label Uses for FDA-approved or cleared
     –   Rapid 3rd Party Payment for New Indications      Drugs & Devices & Build Treatment Protocols
AK
           Nationwide Location of Clinics participating in N-BIRR HBOT 1.5 Study
                 Sponsor: International Hyperbaric Medical Foundation
                    See: http://www.clinicaltrials.gov/ct2/show/NCT01105962
                                This is a Multi-Center Study




                                                                            Locations of Clinics
                                                                           participating in N-BIRR
                                                                              HBOT 1.5 Study
                                                                           Sponsor: International
HI                                                                          Hyperbaric Medical
                                                                                 Foundation

     WIRB-Approved Active Clinics                                                  See:
                                                                          http://www.clinicalt
     Clinics available to join                                            rials.gov/ct2/show/
     WIRB-Approved Clinics on standby                                         NCT01105962
     Warrior Transition Units in US

                                                                                   PR
Pre-Deployment   Post-Deployment   40 HBOT 1.5s   80 HBOT 1.5s
Figure 1:
                                         The passenger side of the M915 truck showing
                                         the damage caused by the IED.




                                                  Conclusion by article authors:
Several aspects of these two cases demonstrate the efficacy of HBO for the airmen treated.
Although both airmen had stable symptoms of mTBI/post-concussive syndrome, which had not
improved for seven months; substantive improvement was achieved within ten days of HBO
treatment. The headaches and sleep disturbances improved rapidly while the irritability,
cognitive defects, and memory difficulties improved more slowly.
Fortunately both airman had taken the ANAM and presented objective demonstration of their
deficits from TBI and their improvements after HBO treatment. Both airmen, who were injured by
the same blast sitting side by side, had similar symptom complexes of TBI and improved at similar
rates after initiation of HBO treatment. Neither airman had any other form of treatment for TBI.
It seems unlikely to the authors that any explanation other than the HBO treatments can be
offered for their improvements.

“Case report: Treatment of Mild Traumatic Brain Injury with Hyperbaric Oxygen:
Colonel James K. Wright, USAF, MC, SFS; Eddie Zant, MD; Kevin Groom, PhD;
Robert E. Schlegel, PhD, PE; Kirby Gilliland, PhD”
ANAM Scores - pre-injury, post-injury, after HBOT
       Budget Savings from Restoring 4 Military Personnel to Duty: $11.2 million
        Long Term Additional Savings: $4 million ($15.2 million) Cost? $100,000

100%




50%




 0
ANAM – CNSVS Comparison
                                     Consistency Between Two Neuropsych Tests
                                                                                                               Executive Function is a Measure of
                                                                                                               the Person’s Ability to Function,
                                                                                                               and Manage Their Daily Affairs
                                                  Change in ANAM Percentiles                                                                                                       Improvement in Percentile CNSVS Scores


                   45.0                                                                                                                             30.0

                   40.0
                                                                                                                                                    25.0
                   35.0
  Percent Change




                   30.0                                                                                                                             20.0




                                                                                                                                   Percent Change
                   25.0

                   20.0                                                                                                                             15.0

                   15.0
                                                                                                                                                    10.0
                   10.0

                    5.0                                                                                                                              5.0
                    0.0
                          Δ Simple



                                     Substitution -




                                                       reaction Time




                                                                        Mathematical




                                                                                       Δ Matching to




                                                                                                       Substitution -




                                                                                                                        Δ Simple
                          Reaction




                                                       Δ Procedural




                                                                                                                        Reaction
                                                                                                                                                     0.0
                                                                                                                         Time ®
                                                                         Processing
                            Time




                                       Learning




                                                                                                         Delayed
                                       Δ Code




                                                                                                         Δ Code
                                                                                         Sample




                                                                                                                                                           Neurocognitive



                                                                                                                                                                            Composite


                                                                                                                                                                                        Verbal Memory



                                                                                                                                                                                                        Visual memory



                                                                                                                                                                                                                        Psychmotor


                                                                                                                                                                                                                                     Reaction Time


                                                                                                                                                                                                                                                     Attention



                                                                                                                                                                                                                                                                 Flexibility




                                                                                                                                                                                                                                                                               Processing


                                                                                                                                                                                                                                                                                            Funtioning
                                                                                                                                                                                                                                                                 Cognitive
                                                                                                                                                                                                                                                     Complex




                                                                                                                                                                                                                                                                                            Executive
                                                                                                                                                                             Memory




                                                                                                                                                                                                                                                                                 Speed
                                                                                                                                                                                                                          Speed
                                                                             Δ




                                                                                                                                                               Index
                                                                       ANAM Test




                                       N=26 All Patients completed at least 40 HBOT 1.5 treatments


Confidentiality Statement applies.
Physical Symptoms Questionnaire
                             Eliminated or Reduced Need For Pain or Sleep Medication:
                             Government Cost Savings as well as Quality of Life Improvement:
                             55% no drugs in Harch Pilot study. 45% reduced need for drugs!




Confidentiality Statement applies.
PHQ-9 Components 7-9
                                                                                               worse

                                                                                    Suicidal
                                                       PHQ 9 (7-9)
                                                                                    thoughts
                                                                                    Reduced!
        1.6
        1.2
Score




        0.8
        0.4
                                                                                                better
          0
                7. Pre HBOT          7. Post HBOT    8. Pre HBOT    8. Post HBOT 9. Pre HBOT 9. Post HBOT
                   Trouble               Trouble       Moving or       Moving or  Thoughts that Thoughts that
                concentrating        concentrating   speaking so     speaking so  you would be you would be
                  on things             on things     slowly that     slowly that better off dead better off dead
                                                     other people    other people   or hurting      or hurting
                                                      could have      could have     yourself        yourself


Pre HBOT                                             “If ANY drug reduced or eliminated suicidal
                                                     thoughts, it should be fast-track researched
Post HBOT                                            and adopted immediately!”
Confidentiality Statement applies.                   James Wright, M.D. (COL, MC, USAF, Ret.)
FDA Cleared HBOT Indications
  HBOT as used by the team is currently in use for 13 FDA-cleared indications (which means the
      manufacturer or practitioner can advertize those indications) by hundreds of physicians at
    nearly 1,000 locations across the nation, delivering approximately 10,000 treatments per day.
                     The thirteen accepted indications for HBOT treatment include:
1. Air or gas embolism.
2. CO poisoning, CO poisoning complicated by cyanide poisoning (Neurological)
3. Clostridial myositis and myonecrosis (gas gangrene)
4. Crush injury, compartment syndrome, and other acute traumatic ischemias
5. Decompression sickness (Neurological)
• Arterial Insufficiency: (Non-Healing Wound)
    Enhancement of healing in selected problem wounds (includes uses like Diabetic
    Foot Wounds, Hypoxic Wounds, and other non-healing wounds, etc.)
7. Exceptional blood loss anemia
8. Intracranial abscess (Neurological)
9. Necrotizing soft tissue infections
10. Osteomyelitis (refractory)
11. Radiation tissue damage (soft tissue and bony necrosis) (Non-Healing Wound)
12. Skin grafts and flaps (compromised) (Non-Healing Wound)
13. Thermal burns[1]
    [1] Hyperbaric Oxygen Therapy: 1999 Committee Report. Editor, N.B. Hampson. Undersea and Hyperbaric Medical Society, Kensington, MD. See also:
    Harch PG. Application of HBOT to acute neurological conditions. Hyperbaric Medicine 1999, The 7th Annual Advanced Symposium. The Adams Mark
    Hotel, Columbia, South Carolina, April 9-10, 1999; and Mitton C, Hailey D. Health technology assessment and policy decisions on hyperbaric oxygen
    treatment. Int J of Tech Assess in Health Care, 1999;15(4):661-70.
HBOT:
 MECHANISMS OF ACTION
     HBOT’s mechanisms of action are well known and well
characterized both in scientific literature and in clinical practice.

 Translational Medicine Methods are Necessary to make these
           treatments for these conditions ROUTINE!
HBOT: It’s About Oxygen Saturation
    The body’s liquids are saturated with more oxygen, helping areas with compromised circulation.




        Before HBOT                                                    After HBOT
Image Courtesy of Dr.
HBOT: Its about the Mitochondria




Image Courtesy of Dr.
HBOT: It’s About Your Own Stem Cells




 In humans, HBOT at 2.0 atm and 100% oxygen for 2
 hours per treatment for 20 treatments increased the
 number of circulating stem cells in the blood by 8-fold

 Thom et al., 2006
 Am J Physiol Heart Circ Physiol 290:1378-86


Image Courtesy of Dr.
HBOT works at the DNA level
                                                                                • Decreases hypoxia-
                                                                                  inducible
                                                                                  factor-1α (hip-1α) &
                                                                                  multiple genes
                                                                                  related to apoptosis
                                                                                • Inhibition of
                                                                                  apoptosis
                                                                                  (programmed cell
                                                                                  death) by HBOT
Zhang, JH et al. Neuroscience and Critical Care Yin, W Brain Res 926: 165-171
                                                                                  translates into brain
Badr et al 2001 brain Res 916: 85-90   Atochin, DN 2000 UHMS 27: 185-190          tissue preservation
  Image Courtesy of Dr.
Micro Air Embolism Contribution to Blast-Induced Mild Traumatic Brain Injury
                                                                                                          Reimers, SD1; Harch, PG2; Wright, JK3; Slade, JB4; Sonnenrein, R1; Doering, ND1
                            1
                             Reimers Systems, Inc., Lorton VA; 2 Clinical Associate Professor and Director; Wound Care and Hyperbaric Medicine Department, LSU School of Medicine, New Orleans, LA; 3Col., USAF MC (ret.), Butte MT; 4Baromedical Associates, Doctors Medical Center, San Pablo CA


                                       INTRODUCTION                                                        Fig. 1: Blast Waves Are More Than Simple Shock Waves, Duration Makes a Difference
                                                                                                                                                                                                                                                                                            RESULTS (CON’D)
 Massive air embolism (AE) from lung disruption is the accepted principal etiology of mortality in                                                                                                                                                       •  In hemodialysis, CNS abnormalities attributed to microbubbles have been correlated with the
 blast injury (White et al., 1971; Sharpnack, Johnson & Phillips, 1990). For sub-lethal blast injury,                                                                                                                                                       duration of dialysis treatment. Barak & Katz (2008) attributed the abnormalities to
 air embolism has been ignored, considered innocuous or believed to have not occurred. The                                                                                                                                                                  microbubbles and stated “a small quantity of microbubbles may be clinically silent, while
 high incidence of post-concussion syndrome (PCS), neurocognitive deficits, and mental health                                                                                                                                                               recurrent exposure has a slow, smoldering, chronic effect” (p. 2921)
 issues resulting from sub-lethal blast injuries in U.S. Iraq and Afghanistan War veterans has                                                                                                                                                           Recent Combat Medical Literature
 vexed military authorities and medical specialists. We propose that micro air embolism is a                                                                                                                                                             • Bauman et al. (2009) provides a summary of the test conditions and initial results from the
 heretofore unappreciated etiologic factor.                                                                                                                                                                                                                 PREVENT (Preventing Violent Explosive Neurotrauma) research program being conducted
                                                                                                                                                                                                                                                            by DARPA. In the tests reported (swine model), the thorax and upper abdomen were
                                                                                                                                                                                                                                                            protected to minimize the possibility of brain injury by indirect pathways. Some neurological
                                MATERIALS AND METHODS                                                                                                                                                                                                       damage was observed, and its significance is still being determined. However, the test
                                                                                                                                                                                                                                                            conditions are of interest as they are also ones where lung injury can readily occur. Point C
 Materials and Methods: Using PubMed, PsychInfo, Google Scholar, Sci.gov, and PubCrawler, a                                                                                                                                                                 on Fig. 1 represents a typical Friedlander wave reported for the blast tube. Test set-ups were
 systematic review of the literature was conducted identifying published papers in the following                                                                                                                                                            built to simulate exposures in the crew compartment of a Humvee with a blast under its floor
 domains: biodynamics and physics of blast overpressure; primary blast injury; microbubbles in                                                                                                                                                              and an open gunner port and in semi-confined space (open top room with dimensions as
 systemic circulation from diving and iatrogenic causes; neurological problems and microbubbles.                                                                                                                                                            shown in Fig 1). In both cases the overpressure durations from a moderate sized charge
 When necessary, key documents were obtained from U.S. Government archives. Reference                                                                                                                                                                       were reported to be about 4 ms. The overpressure data was reported in general form only
 lists of articles were also scanned. Papers with both significant and null findings were included.                                                                                                                                                         without numerical values. However, at 4 ms duration, the pressures required to produce lung
                                                                                                                                                                                                                                                            injury are not large. In situations where the Humvee or building were to be fully closed, both
                                            RESULTS                                                                                                                                                                                                         the magnitude and duration of blast overpressures can be expected to be greater.
                                                                                                                                                                                                          (Note 7)                                       • Buamoul (2009) reports results from a computer model developed by Defence R & D
 Blast-induced AE                                                                                                                                                                                                                                           Canada (CRDC) for estimating the blast damage to the lungs of sheep and humans. He
 • For mammals that die promptly from either air or underwater blast, air embolism has long                                                                                                                                                                 reports the intra-thoracic pressure range currently accepted as the “threshold” for lung
    been recognized as the primary cause of death (Desaga,1950; Shapnack, Johnson & Phillips,                                                                                                                                                               damage is 70 kPa (695 cmH20) to 110 kPa (1,091 cmH20), which corresponds roughly to
    1990; Richmond & Damon, 1991). Lung disruption is proportional to both magnitude and                                                                                                                                                                    the intra-thoracic pressures predicted by the model at exposures near the lung damage
    length of blast overpressurization (Buamoul, 2009) with disruption beginning to occur at                                                                                                                                                                threshold line on the Bowen charts. The intra-thoracic pressures produced by even moderate
                                                                                                        Notes to Fig. 1
    modest overpressures easily within the range of pressures experienced by U.S. combat                2.Figure is based on the survival curves for a 70 kg man where the thorax is near a surface against which a blast wave reflects at normal           size blasts can be very substantial (Fig. 3). They also vary widely with both time and location
    troops from improvised explosive devices (IED) (Fig 1 & 3).                                         incidence (Bowen, Fletcher, & Richmond,1968). data shown is for a single reflection where the total overpressure is ~2x incident                    in the lung, suggesting that opportunities for localized AE may be plentiful. The model also
 • The disruption threshold is lowered by exposures near reflective surfaces, exposures inside          pressure. Total pressures can be up to 8x incident pressure if circumstances are right (Richmond & Damon,1991). In free field exposures             indicates that complex (multi-peak) blast waves can produce higher lung pressures, and
                                                                                                        (no reflections) the damage thresholds are approx. 2x those shown. When used, free field pressure data values are plotted at 50% of
    structures that impede dispersion of the blast gases, and by longer exposure times. It is                                                                                                                                                               therefore greater risk of lung damage than do single peak, classic Friedlander waves of the
                                                                                                        actual.
    further lowered by repeat exposures in less than 24 hours (Stuhmiller, Phillips & Richmond,         3. “Short” and “Long” refer to the ratio of the length of the overpressure region to thorax dimensions. Long blast waves produce much               same impulse value.
    1990).                                                                                              greater chest compression (White et al., 1971).                                                                                                  • Recent work by Yang et al.,1996 (sheep model) suggests the lung damage threshold
 • Benzinger (1950) concluded that because symptoms were only present when a blast hit the              4. Repeat exposures in less than 24 hours, lower the lung damage threshold (Stuhmiller, Phillips & Richmond 1990).                                  pressure may be as much as 75% lower than the Bowen charts (Fig 1) indicate when
                                                                                                        5.The lung damage threshold curve is based on an estimated damage threshold of 20% of the 50% mortality level (White et al., 1971).
    thorax, air embolism must originate in the thorax and becomes effective when it travels to the                                                                                                                                                          the threshold pressure is taken as the lowest pressure at which lung tissue damage
                                                                                                        Recent data (Yang et al., 1996) suggests the threshold pressures for lung damage may be lower (circa 50%) than those shown.
    brain. Benzinger also found that small amounts of air in arterial circulation could readily         6.Blast waveform is also important. However, that is beyond what can be addressed in this poster.                                                   is observable by light and/or electron microscopy.
    reproduce neurologic symptoms seen in blast injury to dogs and humans. Only 1 cc of air             7.A = shock wave period, B= period where expanding blast gases maintain compartment pressure a wave speed of Mach 1. Most blast
                                                                                                                                                                                                   1. Based on                                           •     It is well established that AE is a possible/probable sequelae of exposure to air blast.
    injected into the pulmonary veins of a dog was sufficient to reproduce the                                                                                                                        waves are faster (up to Mach 2+) increasing the
                                                                                                                                                                                                      wave length for the same time..                    •     It is also well established that microbubbles are harmful to brains, and that symptoms may
    electrocardiographic changes seen in blast-injured dogs (Phillips & Richmond, 1990).                                                                                                                                                                       not manifest immediately.
 • Maison (1971) outfitted a dog with a Doppler bubble detector on the carotid artery, exposed            Fig. 2 Blood Velocity & Embolus Indications Following Canine Exposure to LD50 Air                                                              •     Blast overpressure exposures typical of the current wars in Iraq and Afghanistan,
    the dog to an LD50 air blast, and subsequently observed bursts of Doppler deflections going           Blast                                                                                                                                                particularly blast exposures in confined spaces, are sufficient to create risk of lung damage.
    up the carotid correlating with respirations for approximately 30 minutes post-blast. The dog’s                                                                                                                                                            Quickly repeated exposures increase the risk.
    carotid blood flow was observed to temporarily drop to near zero following each group of                                                                                                                                                             •     It is reasonable to expect that the degree of blast-related AE is a continuum ranging from no
    echoes, possibly indicating reduced blood velocity due to temporary distal occlusions (Fig. 2).                                                                                                                                                            bubbles, to a few microbubbles to massive amounts depending on the exposure.
    The dog initially showed severe respiratory distress, but recovered. Postmortem exam                                                                                                                                                                 •     The blast-related intra-thoracic pressures can be very substantial (Fig 3). The range
    showed evidence of residual lung hemorrhage, but no other damage. Maison concluded that                                                                                                                                                                    customarily accepted as the threshold for lung injury is 7 to 11 times higher than the 80
    the bubbles were “clinically silent”.                                                                                                                                                                                                                      mmHg (10.7 kPa) differential known to produce disruption of aveolar-capilary boundary
 • A conceptual model of how AE sequelae to blast exposure occurs, confirmed with rabbit                                                                                                                                                                       tissues in slowly varying pressure environments such as diving (Neuman, 1997).
    model data, can be found in White (1971). Any fast-rising blast pressure wave long enough                                                                                                                                                            •     Work by Yang, et. al (1996) suggests that lung tissue damage, and the concurrent
    to produce significant chest compression is likely to produce some AE.                                                                                                                                                                                     possibility of transient microbubble release, can occur at lung damage levels insufficient to
 • Goh (2009) and Mayo & Kleger (2006) in separate articles regarding civilian blast casualty                                                                                                                                                                  produce clinical blast lung and at overpressures substantially lower than indicated by the
    management advise that AE is a possible complication of exposure to air blast. However,                                                                                                                                                                    widely-used Bowen charts.
    neither author addresses the possibility of neurocognitive sequelae from AE.                                                                                                                                                                         •     The CRDC model confirms suggestions from prior efforts that complex blast waves typical
 • Protective vests reduced mortality & neural fiber degeneration in rats exposed to air blast                                                                                                                                                                 of confined space exposures are more likely to be damaging to lungs than are the simpler
    (Long, et.al., 2009)                                                                                                                                                                                                                                       waveforms typical of free-field blasts.
 Evidence that microbubbles are NOT harmless                                                                                                                                                                                                             •     Blast related bubble production, when it does occur, has been shown to be transient, lasting
 • Microbubbles were first recognized as a medical hazard in open-heart surgery decades ago                                                                                                                                                                    only 15 minutes to 3 hours for significant AE (Mayo & Kluger, 1996). The duration of
    (Barak & Katz 2005). Air emboli from various sources in the extracorporeal circulation (ECC)                                                                                                                                                               microbubble production can be expected to be shorter still making them hard to detect.
    set and tubes can drift into the aorta and systemic circulation, carrying microbubbles to the                                                                                                                                                        •     All recent publications that we found, including a recent review article (Cernak & Noble,
    brain. Clinical results of this unwanted event include major and minor neurologic injury,           Fig. 3 . Lung Injury Prediction from CRDC Model
                                                                                                                                                                                                                                                               2009), were silent on the possible role of microbubbles as a mechanism for blast-related
    neurocognitive deterioration and an overall general decline in patient health (Barak, Nakhoul                                                                                                                                                              brain injury.
    & Katz, 2008; Shaw et al., 1987). The degree of decline in cognitive performance has been                                                                                                                                                            •     When all the factors that may favor microbubble production are considered, it is difficult to
    correlated to the amount of air emboli delivered during the ECC (Deklunder et al., 19981,2).                                                                                                                                                               expect they do not occur.
    Patients with neuropsychological deficits 5 to 7 days after coronary bypass graft surgery                                                                                                                                                            •     Undetected arterial microbubbles have the potential to significantly confound research into
    averaged nearly twice the number of emboli compared to those without deficits (Stump, et al.,                                                                                                                                                              other mechanisms of blast-related brain injury. In research studies where there is a
    1996).                                                                                                                                                                                                                                                     possibility of microbubble production, monitoring for their occurrence is
 • In mechanical heart valve carriers, bubbles are chronically delivered into the arterial system at                                                                                                                                                           recommended.
    variable rates, which can rise as high as 800 per hour in the cerebral circulation. Patients with
                                                                                                                                                                                                                                                             The contribution of micro air embolism to blast-related brain injury may
    these devices have been found to have impairment in episodic memory and deficits in
    working memory (Deklunder et al., 19981,2).                                                                                                                                              Notes to Fig 3.
                                                                                                                                                                                                                                                                    be significantly greater than has been previously believed.
 • Multiple brain lesions in divers with no reported history of neurological DCS have been found                                                                                             2.Data shown are peak intro-thoracic pressures and lung
                                                                                                                                                                                             damage estimates for a complex (2-peak) wave with a
                                                                                                                                                                                                                                                             Available literature suggests that transient AE from primary blast exposure is possible, perhaps
    to be strongly correlated with patent foramen ovale of high haemodynamic relevance. This                                                                                                                                                                 probable, at sub-lethal overpressures similar to the overpressures experienced by U.S. combat
                                                                                                                                                                                             total impulse considered “threshold” for lung damage in a
    finding lead the authors to a hypothesis that the brain lesions were the consequence of                                                                                                  free field (Point D in Fig. 1)                                  Veterans. Arterial microbubbles have been shown to be neurologically harmful and may
    subclinical cerebral gas embolism (Knauth et al., 1997).                                                                                                                                 3.Data from Yang, et.al (1996) suggests the threshold for       contribute to the high incidence of post-concussion syndrome in blast injured veterans. Current
 • A review of 140 cases of delayed DCS treatment (avg. delay 93.5 hrs) reported findings of                                                                                                 “Trace” damage may be significantly lower that assumed
                                                                                                                                                                                                                                                             research efforts are almost exclusively focused on the direct cerebral effects of blast waves. The
    neurocognitive symptoms including severely reduced executive function, apathy and                                                                                                        by the CRDC model.
                                                                                                                                                                                                                                                             AE pathway deserves prompt and thorough investigation.
    antisocial behavior in 49% of the patients. 100% of the neurocognitive symptoms resolved
Copyright: Reimers Systems, Inc. 2011, All rights
    with hyperbaric oxygen therapy. (HBOT) (Cianci & Slade, 2006).
reserved.
Types of Hyperbaric Chambers
HR 396: TBI Treatment Act
•   Subject must have TBI or PTSD and be a Veteran under 66
•   Voluntarily Treated by Civilian Physician
•   ANY FDA-approved or Cleared Treatment (Any Purpose)
•   Must Improve to be Paid
     – Neuropsych Testing (IQ, ANAM, CNS Vital Signs, etc.)
     – Standardized Instruments (PCS, PTSD, Depression Scales)
     – Neurological Imaging (Functional MRI, SPECT, QEEG)
     – Clinical Examination (Coma State, Gate & Balance)
•   Must be Enrolled in IRB-approved Study
•   No Discrimination Against Practitioner for Any Reason
•   Paid 30 days after presentation of valid bill to MM or VA
•   Other necessary protections for the treated veteran
HR396: TBI Treatment Act (Con’t)
• Changes Focus from “Bureaucratic Decision” on Health Care
  Coverage to:
   – “What Actually Worked for the Patient?”
   – ALL TREATMENT MODALITIES INCLUDED
• Outlines a “Rational” Way of Determining What Works and
  What Doesn’t
• HC Provider is ONLY paid if the treatment works (True Pay for
  Performance)
• All data is collected under OHRP Rules for Patient Protection
• Provides Valid Evidence-based Medicine data very
  inexpensively! (10% of the cost of Standard NIH-funded
  Study!)
• As a Principle of Federal Law, the Bill Radically Alters the
  Ability of Patients to get Effective Treatment!
Case Presentation
                  Traumatic Brain Injury from Child Abuse
It is NEVER                     48 y. male                45    Years After
  Too Late!                                                      Injury!




             Scan #1                                  Scan #2

 Image Courtesy of Patient & Dr. Harch: 2002 IHMA Congressional Testimony
Own Your Own Future: Act Now!
• If you or a loved one have a history of TBI or
  PTSD, and are between ages 18-65, enroll in
  NBIRR and get treated NOW!
  – $350 million treats all 14,000 living retired players
  – Insist HBOT be covered by workers compensation
  – Insist HBOT be covered by the “88” Plan
  – Provide funds to a charity of your choice who will
    pay for HBOT for retired football players & others
  – The IHMF: Fund for Veterans and Football Players
• Write Congress about HR 396, the TBI
  Treatment Act, at the IHMA website:
           www.HyperbaricMedicalAssociation.org
THERE IS NO “I” IN TEAM!
• Unite and Change Treatment of Brain Injury
  Forever!
• Save Football, Soccer, Sports for our Youth,
  and help Athletes Recover from their Injuries
• Donate to the Independent Football Veterans
  to help sustain those you enjoyed watching
  in your youth.
• IHMF to get real treatment for Athletes with
  Brain Injury!
Hyperbarics for Athletes Dr Bill Duncan

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Hyperbarics for Athletes Dr Bill Duncan

  • 1. IHMA & IHMF: Sister Organizations Translating Science into Medical Practice and Public Policy to Create Healthcare Solutions for the 21st Century Using Aerospace Medicine in 21st Century Medical Practice Presentation to: Independent Football Veterans Conference Las Vegas, Nevada April 21, 2012 Practical Hyperbaric Medicine for Athletes & Recovering Athletes Using the Principles of Translational Medicine William A. Duncan, Ph.D. Vice President for Government Affairs, IHMA Vice President of Development, IHMF
  • 2. Football is Dangerous! “We Might Have to Do Away with Football” Statement from a U.S. Congress member
  • 3. Fact: Many Sports are Prone to Head Injury Do we do away with all of them? • Soccer • Cheerleading • Snow Boarding • Skiing • Rugby • Horse Sports • Prize Fighting • Rodeo
  • 4. America’s Heroes Answered Our Nations Call Military Medicine Reports 40% have been exposed to blast and RAND reports Over 1/3rd have Suffered Traumatic Brain Injury and/or PTSD • Brian Schiefer is an American Hero • Joint Terminal Attack Controller (JTAC) • 3.5 years to train • One in 1,000 USAF Personnel Qualify • Worth $5 million • After 3 Deployments of over 20 months to Iraq and Afghanistan, Brian was injured during a pre-deployment training exercise at Fort Irwin, CA that left him paralyzed. • He was not evaluated for a brain injury until almost a year and a half after his accident even though incurring a skull fracture to his temporal lobe which resulted in a loss of consciousness. • He was treated with the NBIRR-01 protocol, 80 treatments, and his recovery has permitted him to regain his life and be productive again. • Brian joins many active duty war veterans who were able to continue their careers in the military, and those who Brian Schiefer, USAF. have returned to civilian life with great improvements in Many millions of tax dollars have their quality of life and restored productivity. been saved because of • See Brian’s Story at www.HyperbaricMedicalFoundation.org hyperbaric oxygen therapy!
  • 5. Marine: Battle of Fallujah Never Unconscious Prior to 40 HBOT Treatments Source: Patient’s Family
  • 6. Football Player’s Brain: Avg 200 Concussions Before NFL Play NFL Player & Combat Injuries Similar Images of NFL Player Before & After • The Damage from Multiple Concussions in Sports is very similar Before to the Marine from Fallujah HBOT • Published Reports Estimate the Average NFL Player has sustained 200 concussions before starting to play professional football! • This indicates a tremendous biological reserve capacity in these professional athletes brains! • These athletes likely have “Genius After Level” Reserve Capacity! HBOT • (Discussion on Reserve Capacity: The Oxygen Revolution-Harch-2010)
  • 7. All of These Situations Can Lead to an Untreated Brain Insult • Plus Falls A 9 Mile Per Hour Motor Vehicle • Motor Vehicle Accidents Collision Can Leave • Victims of Crime a Residual Brain • Injury Domestic Violence (UCLA Research)
  • 8. Results of Untreated Brain Insults • 50% Future Lifetime • Incarceration Loss of Income • Anger Issues (including • 45% Unemployed two Road Rage) (2) years post injury • Sleep Disorders • Early Retirement • Depression • Early Onset Dementia • Compulsive Gambling • Homelessness • Dysfunctional Family • Substance Abuse Life • Costs Society $60,000 • Suicide Per Year! One [Brain Injured Person] effects 40 others around them! Alcoholics Anonymous Big Book
  • 9. “Recovery” does not mean “healed without residual effect”
  • 10. Acute Injury? Minutes Matter 71.3 m 12.8 min 5.2 min
  • 11. Current Reimbursed Largely Ineffective Drug Treatments (Symptom Management) Suicides now exceed losses from combat casualties! There is no drug currently approved by the • • Psychiatry (Con’t) Antidepressents (All Black Label Warning Suicide) FDA to treat TBI. The only drugs approved for • Celexa PTSD are Zoloft and Paxil. All other treatment • Lexapro with drugs for these conditions is off-label and • Prozac All in Red carry a black label intended to treat symptoms. In fact, a significant • Luvox warning for suicidality in percentage of psychiatric medications are • *Paxil those under age 25! prescribed off-label. Further, the use of • *Zoloft • Cymbalta antipsychotics in these patients is often as a • The Veteran Suicide Rate is Effexor chemical restraint. • Wellbutrin • Remeron 120 per week! (CDC Numbers) The following list of drugs are FDA approved for • Desyrel psychiatric and neurologic disorders. The great All in Red Fail to beat majority of these drugs have been and are • Antimanic Placebo yet Millions Spent! currently prescribed by DoD Medicine off-label for • Tegretol TBI/PTSD in the service members Dr. Harch has • Lamictal (Journal of Clinical Psychiatry, Nov 29, 2011) treated with HBOT 1.5 in New Orleans. • Eskalith • Topamax Neurology: Psychiatry • Depakote Alzheimer's Anti-anxiety • • Ebixa Lectopam • Antipsychotics August 2, 2011: $717 million • Klonopin Tranxene • Clozaril spent by VA on Drug that does not • Zyprexa • Neurontin Valium • Seroquel work!!! • Lyrica • Risperdal DoD Could have repaired 176,000 • Geodon themselves w/ O2! • Topamax • Abilify “Antipsychotic Doesn’t Ease Veterans’ • Dalmane *FDA Approved for PTSD Post-Traumatic Stress, JAMA Published • Symmetrel Study Finds” - NYTimes.com
  • 12. Non-Healing Wound of the Foot Diabetic Foot Ulcer: This Wagner Grade III was present for one year and unresponsive to conventional therapy. 1 Day Prior to Scheduled Amputation 26 HBOT Treatments Hyperbaric Oxygenation prevents 75% of amputations in diabetic patients. Therapy approved by CMS for Medicare upon application by IHMA to CMS for coverage, 2003. These photographs are the property of Kenneth P. Stoller, MD, FAAP Permission given by Dr. Stoller to the IHMA to publish on this CD (2004) Copyright retained: Kenneth Stoller, M.D., 50 HBOT Treatments 2010 & IHMA
  • 13. Solution? Biologically Repair the Brain Case Published in: Cases Report June 2009 http://casesjournal.com/casesjournal/rt/suppFiles/6538/31370
  • 14. Brain Insults often Result in a 50% Decrease In Brain Metabolism HBOT Restores Brain Metabolism Case Published in: Cases Report June 2009 http://casesjournal.com/casesjournal/rt/suppFiles/6538/31370
  • 15. Solution: It’s Just Oxygen! Oxygen is being used to repair an injury caused by a lack of oxygen! • O2 used in 5,769+ cellular processes Pressure causes • HBOT activates 8,101 Genes! oxygen to – Down Regulates Inflammation Processes – Up Regulates Growth & Repair Processes saturate tissues – Normobaric O2 does not! at 7x to 12x • Simple: Lack of oxygen is bad normal breathing. • We know how it works – Acutely stops swelling/reperfusion injury – Restarts stunned cellular metabolism – Regrows Blood Vessels – Activates Stem Cells 8x Normal • No wound can heal without oxygen – Wounds that have not healed do – Wounds heal 50% faster with less scar tissue – Broken bones 30% faster & 30% stronger • Placebos have to have the potential of HBOT is FDA-approved & available & being inert. Saturating injured tissue with oxygen On-Label for neurological conditions & has never been shown to have a placebo effect! non-healing wounds!
  • 16. Results Speak for Themselves • NBIRR-01 Begins Enrolling Patients March 2010. Preliminary Results from multi-site study support Harch’s Findings. • LSU Pilot Published in the Journal of Neurotrauma, J Neurotrauma. 2011 Oct 25. A Phase I Study of Low Pressure Hyperbaric Oxygen Therapy for Blast-Induced Post Concussion Syndrome and Post Traumatic Stress Disorder PMID: 22026588 – Subjects as a group showed significant improvements on most measures of intelligence, function and quality of life – All subjects received 1/2 the clinically recommended protocol being used in NBIRR-01 ( NCT01105962) – Nearly 15 point IQ Increase (average) (Difference between a high school dropout & a college graduate)(14.8 P<.001 ) – Post-Concussion Syndrome (PCS): 39% Reduction in PCS symptoms (p=0.0002); 87% substantial headache reduction – 30% Improvement in PTSD (20 points of a 62 point scale; a patient must score 50 on to have PTSD “diagnosis”) – 51% Reduction in Depression Indices with Large Reduction in Suicide Ideation(p=0.0002) – 64% had a reduced need for psychoactive or narcotic prescription medications – 92% reported sustained improvement 6 months post treatment – Functional Improvements: Cognitive 39% (p=0.002); Physical 45% (p<0.001); Emotional 96% (p<0.001) • Significant Reduction in Anger Issues! – Placebo Effect Ruled Out! Results too great to be placebo effect and neurological imaging is inconsistent with a placebo effect
  • 17. HOPS: Translating Known Science into Medical Practice • Athletes (Professional & Amateur) have four basic problems – Acute Untreated Brain Insults – Chronic Untreated Brain Insults (prior injuries) – Blunt Trauma Injury & pulled Tendons – Need for Recovery After Strenuous Training – Injuries that may require surgical intervention • IHMF’s Hospital Outcomes & Profit System (HOPS), creates a system that enables acute delivery of consistent HBOT protocols for all indications. Hyperbaric Medical Protocols Currently Exist for ALL of these Challenges
  • 18. As A Professional Football Player Step 1 • Step 1: Reset the Brain’s Reserve Capacity & Function – 80 HBOT 1.5 NBIRR-01 Protocol Treatments & Evaluate – Reserve Capacity Detailed in Harch’s Oxygen Revolution, 2nd Edition, pages 120-128 – NFL Players have Genius Level Reserve Capacity • Reportedly NFL players have sustained, on average 200 concussions BEFORE they start playing pro ball. • Top 1% of High School to College Ball, to 1% of College Ball to NFL • Olympic Level Athletes • Recover Reaction Time, IQ, Executive Function, Memory & Processing Speed
  • 19. As A Professional Football Player Step 2 • Receive Acute HBOT Treatment for any NEW Concussions Using the IHMF’s Acute Brain Insult Protocol (NBIRR-11) • Receive Acute “Sports Injury or Falls” HBOT Treatment for Concussions (NBIRR-11), Blunt Trauma (ACTS-08) or Spinal Cord (Acts-11) or Fracture Protocol (ACTS-09) (Combined as ACTS-05 & ACTS-01 Respectively) • Have Pre-Post Surgery (ACTS-06) for any surgical interventions or repairs
  • 20. Returning Athletes to Competition • U.S. Olympic Team – Treated at San Diego IHMF-NBIRR Site – Sports Injuries – Concussions – Summer & Winter Sports • U.S. Navy SEALs & SOCOM Members – Treated for Fractures – Treated for Knee Replacement – Treated for TBI and PTSD
  • 21. Fractures • Air Force Research Demonstrated that Fractures heal 30% faster and 30% stronger when Hyperbaric Oxygen is used. • Shorter back to work time • Stronger Fusion • Cost Effective through reduced down time The effect of hyperbaric oxygen on fracture healing in rabbits, completed 2003. J Wright
  • 22. Is Hyperbaric Medicine Safe? Source: “HBOT for TBI” Consensus Conference, December 2008 • Treatment involves • The DoD White Paper simply breathing pure stated: “side effects are oxygen under pressure uncommon and severe or permanent complications (often while sleeping or are rare…” (White Paper for watching TV). the HBOT in TBI Consensus Paper, • Ten thousand plus 12/08) • The DoD After Action similar treatments are Report stated: “safety of given every day at the treatment is not an 1,200+ locations issue.” (After Action Report HBOT in TBI nationwide for other Consensus Conference, Defense Centers of Excellence, 16 Dec 2008) indications.
  • 23. Examples: HBOT is Synergistic with Other Treatments • Drug Protocols • Cognitive Rehabilitation – Patients in the LSU Study – Treatment Cannot Begin were on no medication or until a Patient can Sleep less medication Through the Night – Medication was now more – HBOT Repairs Sleep Cycles effective at controlling and most Patients can begin symptoms sleeping at 10 HBOT • Nutritional Programs Treatments – NBIRR Nutritional Program – When Brain Tissue is reduced Aberrant Violent Recovered, it is somewhat Behavior in Felons in 30 RCT disorganized! Studies by 39-41% • Acupuncture – Harch did not use NBIRR • Bio-Feedback supplement in his study • Counseling & Coping Skills
  • 25. Retired NFL Player: Age 58 Pre-Post HBOT 1.5 4+ NFL Players now treated with similar results Source: MicroCog Assessment-- Independent Evaluation by Amen Clinic. NBIRR Subject Courtesy of Dr. Stoller
  • 26. Example of TBI impact assessment in NFL Player Enlarged Fiber Tract showing • NFL football player with fibers from concussive event concussion • Loss of about 2% of the fiber tracts in the region of the corpus callosum. Courtesy Dr. Walter Schneider, U Pittsburgh [fMRI photo] Area of Tissue change Fibers passing through areas
  • 27. Severe TBI Patient: Whole Brain CT Perfusion Pre & Post HBOT Pre HBOT – 10/16/09 Post HBOT – 10/28/09 Images Courtesy of Dr. Germin, Las Vegas
  • 28. IHMF’s National Brain Injury Rescue and Rehabilitation Project NBIRR-01: Mild-Moderate TBI Ages 18-65 • 1,000 patients with mTBI • All participants have and/or PTSD ANY CAUSE improved • 17+ centers • Most improved in every • All receive HBOT measure • Early results encouraging • Most improved • 35 participants in treatment substantially (Mar 2011) • No participants worsened • Results are durable Many are U.S. War Veterans who have had to be treated “for free” by the clinics as charity cases! NBIRR Study, see: http://www.clinicaltrials.gov/ct2/show/NCT01105962
  • 29. John Eisenberg Treatment Registry (JETR) Provides Structure for the NBIRR-01 HBOT 1.5 TBI/PTSD Study & Is a Clinical Research Platform for Translational Medicine Powered by CareVector® • Platform Follows FDA-Devices Methodology for Medical Evidence – IRB Workflow Supports Multi-Site World-Wide Studies – Online Data Entry Forms – Security Roles protect patient privacy • Site Records all DoD ANAM Test Scores Identify & all Other Diagnostics Patient • Screening & Web-based Reporting & Analysis Capture Demographics – 3rd Party Payer/Policy Auditing as Requested – Analysis Tools Available to Auditors Pre-Rx Exam – Permits CMS “Coverage with Evidence” Rules & Testing • All Patients get Real Treatment No Placebo! • NO BARRIER To 3rd Party Reimbursement Treatments – (40 HBOT) Normally “Study” treatments are not reimbursable because of placebo (no) Post-Rx Exam treatment provided. This study design permits & Testing 3rd party payers to pay for treatment and have it tracked for analysis and rapid proofing. Analysis & – Willing to only be paid when the treatment Reporting works under the rules of HR 396, TBI Treatment Act Patient • Evidence-based Medicine Rules & Bayesian Follow-up Analysis Permits – Rapid Publication & Potential FDA Marketing JETR is a Tool Permitting Practitioners to Proof Approval Off-Label Uses for FDA-approved or cleared – Rapid 3rd Party Payment for New Indications Drugs & Devices & Build Treatment Protocols
  • 30. AK Nationwide Location of Clinics participating in N-BIRR HBOT 1.5 Study Sponsor: International Hyperbaric Medical Foundation See: http://www.clinicaltrials.gov/ct2/show/NCT01105962 This is a Multi-Center Study Locations of Clinics participating in N-BIRR HBOT 1.5 Study Sponsor: International HI Hyperbaric Medical Foundation WIRB-Approved Active Clinics See: http://www.clinicalt Clinics available to join rials.gov/ct2/show/ WIRB-Approved Clinics on standby NCT01105962 Warrior Transition Units in US PR
  • 31. Pre-Deployment Post-Deployment 40 HBOT 1.5s 80 HBOT 1.5s
  • 32. Figure 1: The passenger side of the M915 truck showing the damage caused by the IED. Conclusion by article authors: Several aspects of these two cases demonstrate the efficacy of HBO for the airmen treated. Although both airmen had stable symptoms of mTBI/post-concussive syndrome, which had not improved for seven months; substantive improvement was achieved within ten days of HBO treatment. The headaches and sleep disturbances improved rapidly while the irritability, cognitive defects, and memory difficulties improved more slowly. Fortunately both airman had taken the ANAM and presented objective demonstration of their deficits from TBI and their improvements after HBO treatment. Both airmen, who were injured by the same blast sitting side by side, had similar symptom complexes of TBI and improved at similar rates after initiation of HBO treatment. Neither airman had any other form of treatment for TBI. It seems unlikely to the authors that any explanation other than the HBO treatments can be offered for their improvements. “Case report: Treatment of Mild Traumatic Brain Injury with Hyperbaric Oxygen: Colonel James K. Wright, USAF, MC, SFS; Eddie Zant, MD; Kevin Groom, PhD; Robert E. Schlegel, PhD, PE; Kirby Gilliland, PhD”
  • 33. ANAM Scores - pre-injury, post-injury, after HBOT Budget Savings from Restoring 4 Military Personnel to Duty: $11.2 million Long Term Additional Savings: $4 million ($15.2 million) Cost? $100,000 100% 50% 0
  • 34. ANAM – CNSVS Comparison Consistency Between Two Neuropsych Tests Executive Function is a Measure of the Person’s Ability to Function, and Manage Their Daily Affairs Change in ANAM Percentiles Improvement in Percentile CNSVS Scores 45.0 30.0 40.0 25.0 35.0 Percent Change 30.0 20.0 Percent Change 25.0 20.0 15.0 15.0 10.0 10.0 5.0 5.0 0.0 Δ Simple Substitution - reaction Time Mathematical Δ Matching to Substitution - Δ Simple Reaction Δ Procedural Reaction 0.0 Time ® Processing Time Learning Delayed Δ Code Δ Code Sample Neurocognitive Composite Verbal Memory Visual memory Psychmotor Reaction Time Attention Flexibility Processing Funtioning Cognitive Complex Executive Memory Speed Speed Δ Index ANAM Test N=26 All Patients completed at least 40 HBOT 1.5 treatments Confidentiality Statement applies.
  • 35. Physical Symptoms Questionnaire Eliminated or Reduced Need For Pain or Sleep Medication: Government Cost Savings as well as Quality of Life Improvement: 55% no drugs in Harch Pilot study. 45% reduced need for drugs! Confidentiality Statement applies.
  • 36. PHQ-9 Components 7-9 worse Suicidal PHQ 9 (7-9) thoughts Reduced! 1.6 1.2 Score 0.8 0.4 better 0 7. Pre HBOT 7. Post HBOT 8. Pre HBOT 8. Post HBOT 9. Pre HBOT 9. Post HBOT Trouble Trouble Moving or Moving or Thoughts that Thoughts that concentrating concentrating speaking so speaking so you would be you would be on things on things slowly that slowly that better off dead better off dead other people other people or hurting or hurting could have could have yourself yourself Pre HBOT “If ANY drug reduced or eliminated suicidal thoughts, it should be fast-track researched Post HBOT and adopted immediately!” Confidentiality Statement applies. James Wright, M.D. (COL, MC, USAF, Ret.)
  • 37. FDA Cleared HBOT Indications HBOT as used by the team is currently in use for 13 FDA-cleared indications (which means the manufacturer or practitioner can advertize those indications) by hundreds of physicians at nearly 1,000 locations across the nation, delivering approximately 10,000 treatments per day. The thirteen accepted indications for HBOT treatment include: 1. Air or gas embolism. 2. CO poisoning, CO poisoning complicated by cyanide poisoning (Neurological) 3. Clostridial myositis and myonecrosis (gas gangrene) 4. Crush injury, compartment syndrome, and other acute traumatic ischemias 5. Decompression sickness (Neurological) • Arterial Insufficiency: (Non-Healing Wound) Enhancement of healing in selected problem wounds (includes uses like Diabetic Foot Wounds, Hypoxic Wounds, and other non-healing wounds, etc.) 7. Exceptional blood loss anemia 8. Intracranial abscess (Neurological) 9. Necrotizing soft tissue infections 10. Osteomyelitis (refractory) 11. Radiation tissue damage (soft tissue and bony necrosis) (Non-Healing Wound) 12. Skin grafts and flaps (compromised) (Non-Healing Wound) 13. Thermal burns[1] [1] Hyperbaric Oxygen Therapy: 1999 Committee Report. Editor, N.B. Hampson. Undersea and Hyperbaric Medical Society, Kensington, MD. See also: Harch PG. Application of HBOT to acute neurological conditions. Hyperbaric Medicine 1999, The 7th Annual Advanced Symposium. The Adams Mark Hotel, Columbia, South Carolina, April 9-10, 1999; and Mitton C, Hailey D. Health technology assessment and policy decisions on hyperbaric oxygen treatment. Int J of Tech Assess in Health Care, 1999;15(4):661-70.
  • 38. HBOT: MECHANISMS OF ACTION HBOT’s mechanisms of action are well known and well characterized both in scientific literature and in clinical practice. Translational Medicine Methods are Necessary to make these treatments for these conditions ROUTINE!
  • 39. HBOT: It’s About Oxygen Saturation The body’s liquids are saturated with more oxygen, helping areas with compromised circulation. Before HBOT After HBOT Image Courtesy of Dr.
  • 40. HBOT: Its about the Mitochondria Image Courtesy of Dr.
  • 41. HBOT: It’s About Your Own Stem Cells In humans, HBOT at 2.0 atm and 100% oxygen for 2 hours per treatment for 20 treatments increased the number of circulating stem cells in the blood by 8-fold Thom et al., 2006 Am J Physiol Heart Circ Physiol 290:1378-86 Image Courtesy of Dr.
  • 42. HBOT works at the DNA level • Decreases hypoxia- inducible factor-1α (hip-1α) & multiple genes related to apoptosis • Inhibition of apoptosis (programmed cell death) by HBOT Zhang, JH et al. Neuroscience and Critical Care Yin, W Brain Res 926: 165-171 translates into brain Badr et al 2001 brain Res 916: 85-90 Atochin, DN 2000 UHMS 27: 185-190 tissue preservation Image Courtesy of Dr.
  • 43. Micro Air Embolism Contribution to Blast-Induced Mild Traumatic Brain Injury Reimers, SD1; Harch, PG2; Wright, JK3; Slade, JB4; Sonnenrein, R1; Doering, ND1 1 Reimers Systems, Inc., Lorton VA; 2 Clinical Associate Professor and Director; Wound Care and Hyperbaric Medicine Department, LSU School of Medicine, New Orleans, LA; 3Col., USAF MC (ret.), Butte MT; 4Baromedical Associates, Doctors Medical Center, San Pablo CA INTRODUCTION Fig. 1: Blast Waves Are More Than Simple Shock Waves, Duration Makes a Difference RESULTS (CON’D) Massive air embolism (AE) from lung disruption is the accepted principal etiology of mortality in • In hemodialysis, CNS abnormalities attributed to microbubbles have been correlated with the blast injury (White et al., 1971; Sharpnack, Johnson & Phillips, 1990). For sub-lethal blast injury, duration of dialysis treatment. Barak & Katz (2008) attributed the abnormalities to air embolism has been ignored, considered innocuous or believed to have not occurred. The microbubbles and stated “a small quantity of microbubbles may be clinically silent, while high incidence of post-concussion syndrome (PCS), neurocognitive deficits, and mental health recurrent exposure has a slow, smoldering, chronic effect” (p. 2921) issues resulting from sub-lethal blast injuries in U.S. Iraq and Afghanistan War veterans has Recent Combat Medical Literature vexed military authorities and medical specialists. We propose that micro air embolism is a • Bauman et al. (2009) provides a summary of the test conditions and initial results from the heretofore unappreciated etiologic factor. PREVENT (Preventing Violent Explosive Neurotrauma) research program being conducted by DARPA. In the tests reported (swine model), the thorax and upper abdomen were protected to minimize the possibility of brain injury by indirect pathways. Some neurological MATERIALS AND METHODS damage was observed, and its significance is still being determined. However, the test conditions are of interest as they are also ones where lung injury can readily occur. Point C Materials and Methods: Using PubMed, PsychInfo, Google Scholar, Sci.gov, and PubCrawler, a on Fig. 1 represents a typical Friedlander wave reported for the blast tube. Test set-ups were systematic review of the literature was conducted identifying published papers in the following built to simulate exposures in the crew compartment of a Humvee with a blast under its floor domains: biodynamics and physics of blast overpressure; primary blast injury; microbubbles in and an open gunner port and in semi-confined space (open top room with dimensions as systemic circulation from diving and iatrogenic causes; neurological problems and microbubbles. shown in Fig 1). In both cases the overpressure durations from a moderate sized charge When necessary, key documents were obtained from U.S. Government archives. Reference were reported to be about 4 ms. The overpressure data was reported in general form only lists of articles were also scanned. Papers with both significant and null findings were included. without numerical values. However, at 4 ms duration, the pressures required to produce lung injury are not large. In situations where the Humvee or building were to be fully closed, both RESULTS the magnitude and duration of blast overpressures can be expected to be greater. (Note 7) • Buamoul (2009) reports results from a computer model developed by Defence R & D Blast-induced AE Canada (CRDC) for estimating the blast damage to the lungs of sheep and humans. He • For mammals that die promptly from either air or underwater blast, air embolism has long reports the intra-thoracic pressure range currently accepted as the “threshold” for lung been recognized as the primary cause of death (Desaga,1950; Shapnack, Johnson & Phillips, damage is 70 kPa (695 cmH20) to 110 kPa (1,091 cmH20), which corresponds roughly to 1990; Richmond & Damon, 1991). Lung disruption is proportional to both magnitude and the intra-thoracic pressures predicted by the model at exposures near the lung damage length of blast overpressurization (Buamoul, 2009) with disruption beginning to occur at threshold line on the Bowen charts. The intra-thoracic pressures produced by even moderate Notes to Fig. 1 modest overpressures easily within the range of pressures experienced by U.S. combat 2.Figure is based on the survival curves for a 70 kg man where the thorax is near a surface against which a blast wave reflects at normal size blasts can be very substantial (Fig. 3). They also vary widely with both time and location troops from improvised explosive devices (IED) (Fig 1 & 3). incidence (Bowen, Fletcher, & Richmond,1968). data shown is for a single reflection where the total overpressure is ~2x incident in the lung, suggesting that opportunities for localized AE may be plentiful. The model also • The disruption threshold is lowered by exposures near reflective surfaces, exposures inside pressure. Total pressures can be up to 8x incident pressure if circumstances are right (Richmond & Damon,1991). In free field exposures indicates that complex (multi-peak) blast waves can produce higher lung pressures, and (no reflections) the damage thresholds are approx. 2x those shown. When used, free field pressure data values are plotted at 50% of structures that impede dispersion of the blast gases, and by longer exposure times. It is therefore greater risk of lung damage than do single peak, classic Friedlander waves of the actual. further lowered by repeat exposures in less than 24 hours (Stuhmiller, Phillips & Richmond, 3. “Short” and “Long” refer to the ratio of the length of the overpressure region to thorax dimensions. Long blast waves produce much same impulse value. 1990). greater chest compression (White et al., 1971). • Recent work by Yang et al.,1996 (sheep model) suggests the lung damage threshold • Benzinger (1950) concluded that because symptoms were only present when a blast hit the 4. Repeat exposures in less than 24 hours, lower the lung damage threshold (Stuhmiller, Phillips & Richmond 1990). pressure may be as much as 75% lower than the Bowen charts (Fig 1) indicate when 5.The lung damage threshold curve is based on an estimated damage threshold of 20% of the 50% mortality level (White et al., 1971). thorax, air embolism must originate in the thorax and becomes effective when it travels to the the threshold pressure is taken as the lowest pressure at which lung tissue damage Recent data (Yang et al., 1996) suggests the threshold pressures for lung damage may be lower (circa 50%) than those shown. brain. Benzinger also found that small amounts of air in arterial circulation could readily 6.Blast waveform is also important. However, that is beyond what can be addressed in this poster. is observable by light and/or electron microscopy. reproduce neurologic symptoms seen in blast injury to dogs and humans. Only 1 cc of air 7.A = shock wave period, B= period where expanding blast gases maintain compartment pressure a wave speed of Mach 1. Most blast 1. Based on • It is well established that AE is a possible/probable sequelae of exposure to air blast. injected into the pulmonary veins of a dog was sufficient to reproduce the waves are faster (up to Mach 2+) increasing the wave length for the same time.. • It is also well established that microbubbles are harmful to brains, and that symptoms may electrocardiographic changes seen in blast-injured dogs (Phillips & Richmond, 1990). not manifest immediately. • Maison (1971) outfitted a dog with a Doppler bubble detector on the carotid artery, exposed Fig. 2 Blood Velocity & Embolus Indications Following Canine Exposure to LD50 Air • Blast overpressure exposures typical of the current wars in Iraq and Afghanistan, the dog to an LD50 air blast, and subsequently observed bursts of Doppler deflections going Blast particularly blast exposures in confined spaces, are sufficient to create risk of lung damage. up the carotid correlating with respirations for approximately 30 minutes post-blast. The dog’s Quickly repeated exposures increase the risk. carotid blood flow was observed to temporarily drop to near zero following each group of • It is reasonable to expect that the degree of blast-related AE is a continuum ranging from no echoes, possibly indicating reduced blood velocity due to temporary distal occlusions (Fig. 2). bubbles, to a few microbubbles to massive amounts depending on the exposure. The dog initially showed severe respiratory distress, but recovered. Postmortem exam • The blast-related intra-thoracic pressures can be very substantial (Fig 3). The range showed evidence of residual lung hemorrhage, but no other damage. Maison concluded that customarily accepted as the threshold for lung injury is 7 to 11 times higher than the 80 the bubbles were “clinically silent”. mmHg (10.7 kPa) differential known to produce disruption of aveolar-capilary boundary • A conceptual model of how AE sequelae to blast exposure occurs, confirmed with rabbit tissues in slowly varying pressure environments such as diving (Neuman, 1997). model data, can be found in White (1971). Any fast-rising blast pressure wave long enough • Work by Yang, et. al (1996) suggests that lung tissue damage, and the concurrent to produce significant chest compression is likely to produce some AE. possibility of transient microbubble release, can occur at lung damage levels insufficient to • Goh (2009) and Mayo & Kleger (2006) in separate articles regarding civilian blast casualty produce clinical blast lung and at overpressures substantially lower than indicated by the management advise that AE is a possible complication of exposure to air blast. However, widely-used Bowen charts. neither author addresses the possibility of neurocognitive sequelae from AE. • The CRDC model confirms suggestions from prior efforts that complex blast waves typical • Protective vests reduced mortality & neural fiber degeneration in rats exposed to air blast of confined space exposures are more likely to be damaging to lungs than are the simpler (Long, et.al., 2009) waveforms typical of free-field blasts. Evidence that microbubbles are NOT harmless • Blast related bubble production, when it does occur, has been shown to be transient, lasting • Microbubbles were first recognized as a medical hazard in open-heart surgery decades ago only 15 minutes to 3 hours for significant AE (Mayo & Kluger, 1996). The duration of (Barak & Katz 2005). Air emboli from various sources in the extracorporeal circulation (ECC) microbubble production can be expected to be shorter still making them hard to detect. set and tubes can drift into the aorta and systemic circulation, carrying microbubbles to the • All recent publications that we found, including a recent review article (Cernak & Noble, brain. Clinical results of this unwanted event include major and minor neurologic injury, Fig. 3 . Lung Injury Prediction from CRDC Model 2009), were silent on the possible role of microbubbles as a mechanism for blast-related neurocognitive deterioration and an overall general decline in patient health (Barak, Nakhoul brain injury. & Katz, 2008; Shaw et al., 1987). The degree of decline in cognitive performance has been • When all the factors that may favor microbubble production are considered, it is difficult to correlated to the amount of air emboli delivered during the ECC (Deklunder et al., 19981,2). expect they do not occur. Patients with neuropsychological deficits 5 to 7 days after coronary bypass graft surgery • Undetected arterial microbubbles have the potential to significantly confound research into averaged nearly twice the number of emboli compared to those without deficits (Stump, et al., other mechanisms of blast-related brain injury. In research studies where there is a 1996). possibility of microbubble production, monitoring for their occurrence is • In mechanical heart valve carriers, bubbles are chronically delivered into the arterial system at recommended. variable rates, which can rise as high as 800 per hour in the cerebral circulation. Patients with The contribution of micro air embolism to blast-related brain injury may these devices have been found to have impairment in episodic memory and deficits in working memory (Deklunder et al., 19981,2). Notes to Fig 3. be significantly greater than has been previously believed. • Multiple brain lesions in divers with no reported history of neurological DCS have been found 2.Data shown are peak intro-thoracic pressures and lung damage estimates for a complex (2-peak) wave with a Available literature suggests that transient AE from primary blast exposure is possible, perhaps to be strongly correlated with patent foramen ovale of high haemodynamic relevance. This probable, at sub-lethal overpressures similar to the overpressures experienced by U.S. combat total impulse considered “threshold” for lung damage in a finding lead the authors to a hypothesis that the brain lesions were the consequence of free field (Point D in Fig. 1) Veterans. Arterial microbubbles have been shown to be neurologically harmful and may subclinical cerebral gas embolism (Knauth et al., 1997). 3.Data from Yang, et.al (1996) suggests the threshold for contribute to the high incidence of post-concussion syndrome in blast injured veterans. Current • A review of 140 cases of delayed DCS treatment (avg. delay 93.5 hrs) reported findings of “Trace” damage may be significantly lower that assumed research efforts are almost exclusively focused on the direct cerebral effects of blast waves. The neurocognitive symptoms including severely reduced executive function, apathy and by the CRDC model. AE pathway deserves prompt and thorough investigation. antisocial behavior in 49% of the patients. 100% of the neurocognitive symptoms resolved Copyright: Reimers Systems, Inc. 2011, All rights with hyperbaric oxygen therapy. (HBOT) (Cianci & Slade, 2006). reserved.
  • 45. HR 396: TBI Treatment Act • Subject must have TBI or PTSD and be a Veteran under 66 • Voluntarily Treated by Civilian Physician • ANY FDA-approved or Cleared Treatment (Any Purpose) • Must Improve to be Paid – Neuropsych Testing (IQ, ANAM, CNS Vital Signs, etc.) – Standardized Instruments (PCS, PTSD, Depression Scales) – Neurological Imaging (Functional MRI, SPECT, QEEG) – Clinical Examination (Coma State, Gate & Balance) • Must be Enrolled in IRB-approved Study • No Discrimination Against Practitioner for Any Reason • Paid 30 days after presentation of valid bill to MM or VA • Other necessary protections for the treated veteran
  • 46. HR396: TBI Treatment Act (Con’t) • Changes Focus from “Bureaucratic Decision” on Health Care Coverage to: – “What Actually Worked for the Patient?” – ALL TREATMENT MODALITIES INCLUDED • Outlines a “Rational” Way of Determining What Works and What Doesn’t • HC Provider is ONLY paid if the treatment works (True Pay for Performance) • All data is collected under OHRP Rules for Patient Protection • Provides Valid Evidence-based Medicine data very inexpensively! (10% of the cost of Standard NIH-funded Study!) • As a Principle of Federal Law, the Bill Radically Alters the Ability of Patients to get Effective Treatment!
  • 47. Case Presentation Traumatic Brain Injury from Child Abuse It is NEVER 48 y. male 45 Years After Too Late! Injury! Scan #1 Scan #2 Image Courtesy of Patient & Dr. Harch: 2002 IHMA Congressional Testimony
  • 48. Own Your Own Future: Act Now! • If you or a loved one have a history of TBI or PTSD, and are between ages 18-65, enroll in NBIRR and get treated NOW! – $350 million treats all 14,000 living retired players – Insist HBOT be covered by workers compensation – Insist HBOT be covered by the “88” Plan – Provide funds to a charity of your choice who will pay for HBOT for retired football players & others – The IHMF: Fund for Veterans and Football Players • Write Congress about HR 396, the TBI Treatment Act, at the IHMA website: www.HyperbaricMedicalAssociation.org
  • 49. THERE IS NO “I” IN TEAM! • Unite and Change Treatment of Brain Injury Forever! • Save Football, Soccer, Sports for our Youth, and help Athletes Recover from their Injuries • Donate to the Independent Football Veterans to help sustain those you enjoyed watching in your youth. • IHMF to get real treatment for Athletes with Brain Injury!