REHABILITATION OF MILD

TRAUMATIC BRAIN INJURY 

OEF/OIF VETERANS:

A MULTIDISCIPLINARY CHALL

Regina McGlinchey, PhD

Director, Translational Research Center f

TBI and Stress Disorders

( ) TRACTS

)

a

VA RR&D TBI Center of Excellence

VA HSR&D Cyber Seminar Seminar October October 25 2012 ,
Translational Research Center for TBI and Stress Disorders (T

VA RR&D Traumatic Brain Injury Center of Excellence

VA Boston Healthcare Boston Healthcare System: System: TRACTS TEAM

Co‐Director: William Milberg, PhD

Melissa Amick, PhD Marge Ahlquist

Colleen Barber, MS Alexandra Clark

Vitaly Dobromyslin, MS Gheorghe Doros, PhD

Mich l ae Esterman, PhD Joseph DeGutis, PhD

Catherine Fortier, PhD Mary Fitzgerald

Jennifer Fonda, MS Patrick Kilduff, MS

Alexandra Kenna, PhD Andrea Levine, MS

Elizabeth Leritz, PhD Emily Lindemer

Sara, Lippa, PhD Arkadiy Maksimovskiy

Ann McKee, MD Kathleen Moriarty

Ann Rasmusson Rasmusson, MD Walter MustoDavid Salat, PhD Megan Powell

Patricia Resick, PhD Andrew Rosenblatt

Jennifer Vasterling, PhD Sydney Wojtowicz
Challenges of TBI Rehabilitation in OEF/OIF 

Outline

• The scope of the challenge: who is of

particular particular concern concern for the VA in the co

years?

• Why does this cohort represent such a

challenge?

• Considerations for treatment.• Current Current treatment treatment approaches approaches at TRA

mTBI.
The Scope: mTBI

In the US military, TBI is the most common type of phy

injury sustained by OEF/OIF service members, and EXPLO

OR BLAST INJURY by expl i os ve d i ev ces (i i d mprovised expl 

devices, landmines, rockets, etc.) is the most common c

APPROXIMATELY 75% OF ALL TBI’S 

CLASSIFIED AS MILD*

*Center for Disease Con
mTBI

Criteria: must be >0 d d 

for one of thefollowing:

Grade I Grade II Gr

Loss ofConsciousness (LOC)

None <5 minutes 

Post Traumatic 0‐15 minutes <24 hours but > 15 

Amnesia (PTA) minutesAlteration of MentalStatus (AMS)

0‐15 minutes <24 hours but > 15

minutes

Status (AMS) minutes

Developed based o
Understanding the Complex Physical and Men

of OEF/OIF OEF/OIF Veterans: Veterans: TRACTS Core Assess

Assess

Medical/Biolog Neuropsych Affective/Psyc Blast & TBI ical Domains hosocial Blood Chemistry Simple & Divided

Attention

PTSDCAPS & PCL‐C

Boston Assessment

TBI‐Lifetime

Genetic Information

Processing Speed

DSM‐IV AXIS I:

SCID

Ohio StateUniversity TBI ID

Neuro‐steriod Executive Function Traumatic Life

Events

NeurobehavioralSymptom Inventory

Events

Questionnaire

Symptom Inventory

Declarative &Procedural Memory

Deployment Risk &Resiliency Inventory

Pre‐morbid

Function

Depression, Anxiety& Stress Scale‐21

Perception Pittsburg Sleep

Symptom Validity McGill‐Pain

Psychomotor Speed ETOH, Nicotine

Sickness Impact

Profile
Demographics/Deployment Informat

TRACTS Cohort

(

n=198)

Variable Mean (SD

Gender 87% male

13% female

Age 33.2 years (8.60)

Range: 20‐62

Ethnicity White/Caucasian 6

Hispanic/Latino 1

American Indian 

Asian 2.5%

Black/African America

Years of Education 13.91 (1.97)

Range: 12‐20

Estimate IQ 100.58 (11.70)

Range: 66‐12

Number of Deployments 1.37 (0.65)

Duration of Deployments (months) 14.72 (8.85)

Time

since l t as

Dl t ep oyment ( th ) month

s) 33 15 . (26 47) .
Why does this cohort represent 

challenge?

HETEROGENIET
Traumatic Brain Injury in OEF/OIF

Boston Assessment of TBI‐Lifetime (BAT‐L

Deployment Blast Military “Other” Pre‐Deployment Po

Severe 0 0 2 Moderate 02 4 Mild 42 (21%) 52 (26%) 77 (39%) 

(6 with multiple)

52 (26%)

(14 with multiple)

77 (39%)

(27 with multiple)

Stage

1

20 26 31 

Stage

2

19 24 36 

Stage

3

3210 
Heterogeneity of mTBI:

Outlier Maps of Cortical Thin
Simultaneity of Physical and Psycho

Trauma in OEF/OIF
Post‐Traumatic Stress Disorder

Clinician‐Administered PTSD Scale (CAPS)

Current Pre‐Deployment Post‐Deployme

119 (60%) 35 (18%) 128 (65%)
Percentage of TRACTS Cohort (n=

Military mTBI and Current PTS

8% mTBI Only

27%

32% PTSD Only

Co-occurring mTBI + Deployed (neither)

33%

Only 8% with uncomplicated mTBI60% with PTSD; 33% with Co‐occurring occurring mT
Percentage of TRACTS Cohort (n=

Lifetime Hx mTBI and Lifetime Hx 

11% 13% mTBI Only

PTSD OnlyCo-occurring mTBI Deployed (neither)

22%

55%

21% of “deployed controls” have TBI and/or PTSD68% with lifetime history of TBI; 5occuring PTSD
Lifetime versus Current CAPS Score on 

Brain Structure 
mTBI is a Poly-Morbid Condition 

OEF/OIF 

VETERANS 

WITH mTBI 

(n=81) 

PTSD 

80%

Other ANXIETY 

Disorder 

17%

MOOD 

Disorder 

42%

ALCOHOL 

Abuse/Dependence 

24%

OTHER SUBSTANCE 

Abuse/Dependence 

2%

PAIN 

73%

SLEEP Disturbance 

80%
Number of Co-morbidities 

# of Comorbidities 

(n=198):

0 1 2 3 4 5 6

3 

or 

more

# Service 

Members 

(%)

18 

(9%)

34 

(17%)

40 

(20%)

37 

(19%)

45 

(23%)

20 

(10%)

4 

(2%)

106 

(54%)

# of Comorbidities 

(n=81): 0 1 2 3 4 5 6

3 

or 

more

# Service 

Members 

(%)

1

(1%)

12 

(15%)

11 

(14%)

20 

(25%)

22 

(27%)

14 

(17%)

1 

(1%)

57(70

%)

THOSE WITH mTBI 

Entire TRACTS sample 
Biomedical Characteristics 

Measure TRACTS (n=198) mTBI (n=81) Normal 

Mean Arterial Blood Pressure 89.83 ± 10.09 91.28 ± 9.48 70-110

Systolic Blood Pressure 116.86 ±12.75 118.16 ± 11.36 110-130

Diastolic Blood Pressure 76.32 ± 9.84 77.84 ± 9.50 75-85

Body Mass Index 28.60± 4.66 29.27 ± 4.76 18.5-24.9 

Waist-Hip Ratio .87 ± .08 .88 ± .09 ≤.95 M/≤.80 F

Total Cholesterol 188.11 ± 37.29 191.93 ± 35.68 <200

LDL - Cholesterol 115.69 ± 33.72 118.35 ± 30.04 <100

HDL - Cholesterol 48.18± 12.71 48.06 ± 12.58 >60

Triglycerides 140.65 ± 121.21 146.14 ± 136.15 <150

Cardiac Homocysteine 10.55 ± 3.14 10.30 ± 2.26 <11.4 

Glucose 86.13 ± 37.17 82.42 ± 12.04 65-99

Hemoglobin A1-C 5.45 ± .87 5.39 ± .27 <5.7 

C-Reactive Protein .24 ± .24 .26 ± .29 <.80 
SO WHAT? 

MANY OF THE CO-MORBID CONDITIONS SHARE 

THE SAME UNDERLYING NEURAL STRUCTURES 

AND SYSTEMS. 

For example: 
Cholesterol: Leritz et al. 2010 Alcohol: Fortier et al. 2011 

PTSD: Salat et al. 2012 
Not surprising....Shared Cognitive Dysfunction

Persistent

mTBI

PTSD Alcohol

Abuse/Depende

nce

Cardiovascular

Risk

Pain Sleep

Memory Memory Memory Memory Memory Memory

Attention/Conce

ntration

Attention/Conce

ntration

Attention/Conce

ntration

Attention/Conce

ntration

Attention/Conce

ntration

Attention/Conce

ntration

Executive 

Functions

Executive 

Functions

Executive 

Functions

Executive 

Functions

Executive 

Functions

Executive 

Functions

Headache Headache Headache Headache

Fatigue Fatigue Fatigue Fatigue Fatigue Fatigue

Hyperarousal Hyperarousal

Avoidance Avoidance Avoidance Avoidance Avoidance

Light Sensitivity Light Sensitivity Light Sensitivity

Insomnia Insomnia Insomnia Insomnia Insomnia

Depression Depression Depression Depression Depression Depression

Irritability/Anger Irritability/Anger Irritability/Anger Irritability/Anger Irritability/Anger

Dizziness Re-experiencing Dizziness Dizziness Dizziness
Considerations Before Treatment to Maximize 

Potential Outcome 

1. Blood work/physical to check for CVD risk factors out of 

range that could impact cognition and brain function (e.g., 

hypertension, cholesterolemia, liver function, etc.). 

1. Full assessment of cognitive function to identify domains 

of decreased ability and identify strengths that can serve 

as a basis for rehabilitation. 

1. Control of substance abuse/dependence. 

1. Management of chronic pain and sleep disturbance. 
TRACTS Rehabilitation Programs 

• Cognitive Processing Therapy for co-occurring 

mTBI and PTSD (Ann Rasumusson, PI) 

• Vocational Rehabilitation for OEF/OIF Veterans 

(Colleen Barber, PI) 

• Cognitive Behavioral Therapy for 

Posttraumatic Headache for OEF/OIF veterans 

(John Otis, PI) 

• Remediation of attentional dysfunction in 

mTBI and/or PTSD OEF/OIF veterans 
Sustained Attention in TBI/PTSD 

10

• TBI, PTSD, and deployment alone have been associated with increased 

distractibility and impaired sustaining attention 

 - Difficulty maintaining a focused and engaged state of attention 

• Sustained attention deficits may underlie other deficits such as impulse 

control, decision-making, and emotion regulation Sustained Attention Performance 

Alertness 

low medium high 

poor 

good 

Anxious, 

Distractible 

Relaxed, 

Focused, 

On-task 

Disengaged 
Sustained Attention Training (TAPAT) 

Pre-determined 

Target 

+ 

Hit + 

spacebar 

Withhold 

response 

+ 

+ 

+ 

500ms 

1000ms 

2000ms 

500ms 

500ms 

Hit

spacebar 
Sustained Attention Training: Pilot Results 

Impulse Control Distractibility (Conflict effect) 

PTSD 

PTSD 

 PTSD 

+TBI 

 PTSD 

+TBI 

• All participants significantly improved at sustaining attention 

on the training task itself 

• Participants also improved on impulse control and showed 

reduction in distractibility 
Lessons Learned 

• Cannot think of mTBI in OEF/OIF Veterans as something that 

can be treated in isolation of other prominent co-morbid 

conditions. 

– mTBI IN THIS COHORT RARELY EXISTS ALONE 

• Very difficult cohort to engage and retain in modular 

therapies. 

• Treatment compliance affected by ongoing factors such as 

pain, sleep disturbance and substance use/abuse. 
Lessons Learned 

• Critically important to consider cognitive, especially executive 

function deficits, as moderators of therapeutic processes 

(e.g., engagement and participation). 

• Presence of cognitive deficits require flexible approaches to 

rehabilitation. Clinical materials and method of presentation 

should be tailored to fit the needs of the patient. 

Strict adherence to protocol may not be clinically beneficial. 
Use a Patient-Centered Approach!! 

ONE SIZE WILL NOT FIT ALL 
US Department of Veterans Affairs 

Telerehabilitation for Veterans 

with Combat Related 

Traumatic Brain Injury 

Kris Siddharthan, PhD 

James A Haley Veterans Hospital 

Tampa, Fl 

Award Number : W81XWH-08-2-0091 

Award Dates: June, 2008 – June 2013 

 

 
Background/rational 

• OEF/OIF wounded > 35K 

• Incidence of TBI /PTSD : 60% 

• Long term rehabilitation 

• VA resources limited 

• Alternate modalities of care coordination 

• Telerehabilitation 
Objectives 

1. Evaluate the efficacy of telerehab for 

care coordination. 

2. Monitor physical and mental health 

outcomes. 

3. Determine if telerehab is cost effective. 

4. Capture patient satisfaction with 

telerehab for combat trauma. 
Study Design 

• 36 month design with a convenience sample 

of 75 OEF/OIF returnees. 

• quantitative analysis of 

–Health outcomes, utilization, cost 

• qualitative analysis of 

– veterans’ perceptions of telerehab

– Facilitators and barriers to implementing 

telerehabilitation 
Inclusionary criterion 

• Returnees from Iraq and Afghanistan with a 

clinical diagnosis of mild/moderate TBI. 

• Use the James Haley Veterans Hospital as 

primary source of care 

• Will benefit from the program 

• Not institutionalized or psychotic. 
Telerehab Intervention 

• Full time interventionist (ARNP) 

• MD’s: primary care and specialists 

• Psychologist 

• Computer based 

• Internet: Secure VA server 

• Individual dialogues 

• Asynchronous chat 

• Text alerts 
Telerehab intervention 

Care coordination 

a) Scheduling appointments 

b)Pain management 

c) Drug therapy 

d) Substance abuse 

e) Counseling 

f) Behavior modification 
Monitoring Health Status 

• Activities of daily living 

• Cognition 

• Integration into society 

• Psychosocial status 

• Depression 

• Musculoskeletal disorders 

• Adverse events 
Instruments 

• Functional Independence Measures 

• Craig Handicap Assessment and Reporting 

Technique (CHART) 

• Patient Competency Rating Scale 

• Beck Depression Inventory 

• Modified PTSD Symptom Scale 

• Alcohol Use Disorders Identification 

• Medical Outcomes Social Support Survey 
Veteran Demographics 

N=75 TBI Cohort TBI/PTSD Cohort

Gender N % N %

Female 3 4.0% 0 0.0%

Male 58 77.3% 14 18.7%

Race/Ethnicity

Black 4 5.3% 0 0.0%

Hispanic 15 20.0% 4 5.3%

Native Hawaiian 1 1.3% 1 1.3%

Unanswered 2 2.7% 1 1.3%

White 39 52.0% 8 10.7%

Age

18-29 30 40.0% 3 4.0%

30-39 18 24.0% 3 4.0%

40-49 10 13.3% 6 8.0%

50+ 3 4.0% 2 2.7%
Rehabilitation trajectories 
Linear Latent growth curve models 

• Dependent Variables: subscales 

– Craig Handicap Assessment and Reporting 

Technique 

– Patient Competency Rating Scale 

– FIM + FAM 

• Adjusted for age, % service connected 

disability, marriage status, PTSD and 

interaction terms. 
Results 

• PTSD significant predictor in 

– CHART 

• Social integration 

• Mobility 

• Physical independence 

– FIM + FAM 

• Cognitive function 

• Communication items 

• Psychological adjustment 

• Mobility 
Summary of Findings 

• Physical Symptoms (locomotion, mobility) 

have stabilized 

• Problem areas 

– Cognition (memory, problem solving) 

– Psychosocial adjustment (anger, emotional 

status) 

– Integrating into society 

– Suicidal tendencies 
Conclusions 

• Individualized treatment pathways 

needed. 

• Alcohol and substance abuse complicates 

treatment. 

• Fragmented care delays recovery. 

• Veterans are appreciative of the 

program. 
Transition to My HealtheVet 

• Secure messaging (Veterans/caregivers) 

• Provider Panel 

– Primary Care Physician 

– Clinical Psychologist 

– Neurologist 

– Social WorKer 

– Point of Contact (RN) 

 
 Questions ? 
Controversies in the Use of

HBO f S t ti TBI 2 or Symptomatic mTBI

David X. Cifu, M

National Director, PM&R Se

Department of Veterans Af

Chairman and Herman HJ. Flax, M

Department of Physical Medicine and 

Virginia Commonwealth UnivVirginia Commonwealth Univ

DCIFU@VCU.EDU
Topic Outline

• Why is DoD/VA studying studying HBOT for TBI ?• Examining Theory – A Role for HBO2 aft• Applying HBO2 to PCS – Trials & Tribulat
Why is DoD/VA studying studying HBOT for T
Why is DoD/VA study g in HBOT for 

• Increasing incidence of TBI in Military a

Veteran populations.

• Persistence of symptomatic mTBI after 

related injuries.

• Pressures from VSO, Lobbyists Lobbyists, constitu

constitu

• Pressures from Congress and DoD leade
Why is DoD/VA studying studying HBOT fo

• Increasing Increasing incidence incidence of TBI in Military Military a

Veteran populations.
The Impact of TB

• Civilian TBI experience

– Most common cause of disability disability / death – 3.5 million TBIs annually– TBI di bilit disability i 2% n US popul ti a on; 50 00

, 

– 80% mild, 10% moderate, 10% severe

– $56 3 billi / $56.3 billion/yr

CDC
The Impact of TBI

Mechanisms of Injury – Military 
The Impact of TBI

Mechanisms of Injury – Military no
The Impact of TB

TBI in U.S. Military 2000-2012

(2000 
Iraq/Afghan Wars and 

• 15‐23% of all deployed SMs have TBI or ~350,000

>233,000 confirmed by DoD2

~ 2 500 , mod/severe

• 7‐8% of all OEF/OIF OEF/OIF SMs who have come to VA (7

7

55% of those eligible) have symptomatic mTBI3

• 73% of Vets with symptomatic mTBI also have m

diagnosis (usually PTSD)3

1Cong g ressional Budget Office2www.dvbic.org/tbi-numbers.aspx3www.queri.research.va.gov/ptbri/docs/v
Costs of OEF/OIF TBI care in V

FY2011

• PTSD alone = $ 8,300• TBI alone = $11,700*• TBI + PTSD = $13,800*

* excludes all inpatient rehab

• N ith e er = $ 2 400 ,• Ttl o a = $2 billion of overall care

Source: Congressional Budge
Why is DoD/VA studying studying HBOT fo

• Persistence Persistence of symptomatic symptomatic mTBI after 

related injuries.
Persistent Symptoms after 

Di i zz ness A tit hLoss of BalancePoor coordination

Appetite changePoor concentration

Poor coordination ForgetfulnessHeadachesHeadachesNausea

ForgetfulnessDifficulty making de

Nausea Slowed thinkingVisual disturbanceLight sensitivity

Slowed thinkingFatigue

Light sensitivity InsomniaInsomniaHearing difficultyNoise sensitivity

InsomniaInsomniaFeeling anxious

y Feeling depressed

Body/extremitynumbnessnumbness

g p 

Easily irritatedPoor frustration tol

Altered Altered taste or smell Cicerone: Cicerone: J Head Tr Rehabil Rehabil 199

199
Epidemiology: Overlap 

PT

S

D

2 9%

68.2%

2.9%

16 5%

6.8%

5 3%

16.5%

42.1% P

6

Pain81.5%

10.3%

5.3%

12.6%

81.5% 6

10.3% 12.6%

Lew: J Rehabil Res D
PDS: A Complex Cond

Complex Cond

Mild TBI Combat‐relate

Blast

Post Deployment

Syndrome

Sub

Depression

Pain Environment Systemic Fa
Why is DoD/VA studying studying HBOT fo

• Societal Societal Pressures Pressures for mTBI Treatments Treatments
Societal Pressures Pressures for mTBI Tr

Tr

Belief that current TBI “treatments” a

proven and non‐sci ifi ent c.

Concern for long‐term effects of mTBI

Less an issue of disabling impact of symptoms

Strong focus on Chronic Traumatic Encephalopat

Anecdotal reports of efficacy with HBO

Financial rewards.

Testimonials from patients.
Why is DoD/VA study 

i

HBOT for TBI ?

Concern for troop readiness.Concern for troop recruitment.

High profile profile of Congresswoman Congresswoman Giffor

Giffor

DoD and VA need to lead the way.
PCS Pathop y gy hysiology

The Cell’s Perspective

Primary Insult Effects

Direct Mechanical Damage at Time of I

Respond to Preventive Preventive Measures Measures

Secondary Insult Effects

Delayed Non‐Mechanical EffectsRespond to Treatment Measures
PCS Pathop y gy hysiology

The Cell’s Perspective

Initial Stages of Injury

Direct Tissue Trauma

Impaired Blood Flow

CO2 ResponsivenessVasospasticityHyper / Hypoperfusion

Impaired Regulation Metabolism Metabolism

Increased Cellular WorkGlucose / L tt ac a e I bl m a ance
Examining y Theor

A Role for HBO2 in PCS?

fÇt~x b|ÄfÇt~x b|Ä Scie

Politics

or...
Examining y Theor

Potential HBO2 Applications to T

HBO2 Mechanism Acute TBI Chronic TB

Diffusion and Mechanical 

Compression

Modulation of Antibacterial

Not Applicable Not Applicable

Modulation of Antibacterial

Response

Correction of Cellular 

H i

Not Applicable Not Applicable

Likely Possible Hypoxia

Vasoconstriction

R f i Ij

Likely

Likely Unlikel

Reperfusion Injury

Prophylaxis 

Stimulation of Cellular Possible

PossiblePossible

Unlikel

Repair
Examining y Theor

Proposed HBO2 Effects on TBI

Bottom Line – Basic Science Still Lack
Controversies in the Use o

Talking to the Animals

Systemic review of animal (rodent, cat, 

research research s pports supports HBO se in ac te TB

2 use in acute TB

Acutely, HBO2 significantly

Reduces acute cerebral edema

Reduces markers of cerebral inflammation

Increases cerebral perfusionEnhances spatial learning / task

Shown also to enhance cognitive outco

chronic moderate‐severe TBI
Controversies in the Use o

Talking to the Animals

Caveats in examining animal literatu

HBO2 treatment initiation

Animals usually g be un minutes to 2 hours Humans usually 6+ hours to days post‐inju

No HBO2 No HBO research in mTBI (acute or ch

2 research in mTBI (acute or ch

mTBI animal model lacking and PCS ha

understand in animal

No direct translation of animal TBI wor
Controversies in the Use o

The Human Research Experie

Human Studies

Four Systematic Reviews

Included 23 publications (1972‐2001)

Only four studies studies (382 subjects subjects, 199 HBO & 1

2 & 1

met review criteria for scientific evaluation

Assessed acute, traumatic, moderate‐severe T

Concluded current scientific evidence insuffic

effectiveness / ineffectiveness of HBO2 for TB

Two reviews and two trials published sinc
Controversies in the Use o

The Human Research Experie

– Summary of acute human usage (in seve

• One trial showed trend (P < 0.08) towards f

outcome at 1.5 years post‐injury.

– Three trials showed a significant reduction 

95%CI 0.54‐0.88) in risk of dying (mortality) 

‘numbers needed to treat’ being 7.

– No reduction in coma persistence or durati

• Enhanced mortality seem to be related to e

ICP and pulmonary status
Controversies in the Use o

The Human Research Experie

Summary of adverse events (186 pat

4 studies) = 11 3%.

Three Seizures – 1.6%Fif l teen Pulmonary Symptoms – 8%

Two Otic Barotraumas – 1.1%
Controversies in the Use o

The Human Research Experie

Caveats of Human Literature:

O ll vera st du y quality assessed l as ow

No sham therapy included

Rd i i andomization i d na equate

Blinding not used

Non‐stand d ar inclusion criteria across tria

No scientifically rigorous human research 

publi h d blished in acute mild/ d mo erate TBI or c

of any severity.
The C t urren Cli i l n ca Ti l r a s in the D Do 

• There are presently 4 DoD supported HBOT tr

persistent sy p m toms after mTBI.

– Pilot study (HBOT vs Sham) completed– Pilot study (outcome measure validation) complet– Pilot study (HBOT [2 dose] vs Sham) underway – 6

completed

– Definitive trial begun January January 2012

• There is also 1 non‐DoD open‐label trial (Harc

underway

– Non‐randomized

– No sham or control
Controversies in the Use o

The Current Clinical Tria

International Hyperbaric Medical Foundation (15APR2010) – Act

Multicenter Observational Trial Hyperbaric Oxygen T

Study Name Multicenter Observational Trial Hyperbaric Oxygen T

Traumatic Brain Injury or Post-Traumatic Stress Disor

PIs Dr. James Wright & Dr. Paul Harch

Sites Multiple sites: currently 14 active, but number not spe

Inclusion 

Criteria

18-65 years old, mild – moderate TBI or PTSD, diagn

evaluation, p 20%erformance decrement on ANAM / “

Study Design Observational, Prospective, Unblinded, Self Control C

Study Tests Not Disclosed

Protocol 

Groups

All subjects receive intervention (1.5 ATA oxygen, 60 Plan 40 sessions, but extend “as indicated” to 60 – 80 

Results Improvements seen on all measures (function, neurops
Controversies in the Use o

The Current Clinical Trials

Intermountain Health Care, Inc. (27JAN2009) – Comp

Study Name Study Name Hyperbaric Oxygen Therapy in Chronic Stable Brain I

Hyperbaric Oxygen Therapy in Chronic Stable Brain I

PIs Dr. Lin Weaver & Susan Churchill, APRN-NP

Sites LDS Hospital, Salt Lake City, Utah

Inclusion 

Criteria

18-80 years old, chronic, stable, mild brain injury sequto stroke, anoxia or trauma), confirmed by questionnai

Study Design Study Design Observational Prospective Unblinded Self Observational, Prospective, Unblinded, Self-Control C

Control C

Study Tests Neuropsychological testing, functional measures, heal

of life measures, and neurological examination, subjec

Protocol 

Groups

All subjects receive intervention (1.5 ATA oxygen, 60 door”), 60 total sessions

No significant effects of HBOT Subjects tolerated ses

Findings No significant effects of HBOT. Subjects tolerated ses

Measurement tools tolerated and reproducible.
Controversies in the Use o

The Current Clinical Trials

US Air Force Trial (17DEC2008) – Completed

Treatment of Moderate to Mild Cognitive Dysfunction 

Study Name

Treatment of Moderate to Mild Cognitive Dysfunction 

Traumatic Brain Injury (TBI) with Hyperbaric Oxygen (HBOT)

PIs C l R b t Mi h l M j G ld Y k C l ( t) G 

Col Robert Michaelson, Maj Gerald York, Col (ret) Ge

Sites San Antonio Military Medical Center, San Antonio, Tx

Inclusion 19-60 years old, mild – moderate TBI, researcher conf

Criteria

y , , 

stable status and medications

Study Design Randomized, Prospective, Sham Controlled, Single Bl

SdT tuy ests I PACT ANAM TOVA PCL ImPACT, ANAM, TOVA, PCL-M fMRI Bi k M, fMRI, Biomarkers 

Protocol 

Groups

Sham – 1.3 ATA Air (3 x 30 min, w / 10 min air breaksHBO2 – 2.4 ATA Oxygen (3 x 30 min, w / 10 min air b

Findings Significant improvement in both groups on ImPACT a

but no b/n group differences.


Controversies in the Use o

The Current Clinical Trials

VCU - VA - US Navy Trial (06OCT2010) – Active / Recru

Study Name Hyperbaric Oxygen Therapy (HBO2T) for Post-ConcussStudy Name (PSC) After Mild Traumatic Brain Injury (mTBI)

PIs Dr. David Cifu, CAPT Brett Hart, Dr. William Walker

Hunter Holmes McGuire VA Medical Center Richmond 

Sites Hunter Holmes McGuire VA Medical Center, Richmond, 

Naval Operational Medicine Institute, Pensacola, FL – H

Inclusion 

C it i

19-60 years old, chronic, stable, mTBI, researcher confir

Criteria questi i / t ti tionnaires / testing

Study Design Randomized, Prospective, Double Blind, Sham Controlle

Study Tests 9 Sy p , py , p mptom Assess, 12 Neuropsych, Computerized Postu

Protocol 

Groups

Group A: 2.0 ATA (100% O2 - 2.0 ATA Equivalent), 40 S

Group B: 2.0 ATA (75% O2 - 1.5 ATA Equivalent), 4

Groups min

Group C: 2.0 ATA (10.5% O2- 1.0 ATA Equivalent), 40 S
Controversies in the Use o

The Current Clinical Trials

US Army MRMC Trial (24FEB2011) – Active / Recrui

Study Name A Pilot Phase II Study of Hyperbaric Oxygen for Persis

Concussive Symptoms after Mild Traumatic Brain InjuConcussive Symptoms after Mild Traumatic Brain Inju

PIs Col Scott Miller, Dr. Lin Weaver, Susan Churchill, Dr. 

Naval Hospital Camp Pendleton, CA - Por

Sites Evans Army Hospital , Ft. Carson, CO - Port

Eisenhower Army Med. Center, Fort Gordon, GA - F

Inc us o l i n 18-65 years old, Cohort 1 – PTSD, Cohort 2 – chronic, 

Criteria

ye s o d, Co o S , Co o c o c, 

researcher confirmed by questionnaires / testing

Study Design Randomized, Prospective, ± Single Blind, Sham Contro

Study Tests RPQ, NSI, 19 Others Secondary, Dynavision, 6-Minute 

Cohort 1(a): PTSD, No Intervention, Local Care

Protocol 

Groups

Cohort 2(b): mTBI, No Intervention, Local CareCohort 2(c): mTBI, Active (1.5 ATA Oxygen, 60 min), Cohort 2(d): mTBI, Sham Control (1.2 ATA Air, 60 min
Controversies in the Use o

HBO2 for PCS – Concluding Concluding the 

• Mild TBI is in the spotlight.• Increasing rumors that mTBIs are mo

malignant than previously believed.

• Increasing rumors that treatments fo

symptoms associated associated with mTBI are

ineffective.

• Increasing Increasing rumors that HBOT may of

answer .
Controversies in the Use o

HBO2 for PCS – Concluding Concluding the 

• Management of symptomatic TBI is 

at being “curative curative”

• Symptomatic Treatment• Reassurance

• HBO2 (or at least pressurization or ot

sham) may have a role in treatment treatment.

• Multiple HBOT trials ongoing.

• HBOT is not appropriate for TBI treat

based on current research evidence.
HBOT for symptomatic mT

Pass (on) the Gas (for now

Questions?