Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI)

Persistent post-concussive symptoms from mild traumatic brain injury are a severe issue
facing the readiness, retention and quality of life of Department of Defense(DoD) service
members and Veterans. The inadequacy of established treatment regimens and evidence-based
science in post-concussive symptoms (PCS)/MTBI is forcing a closer look at non-conventional
treatments of this condition. Hyperbaric oxygen (HBO2) is a potent intervention with
demonstrated efficacy in dive-related injuries, soft tissue healing, and carbon monoxide
poisoning.

This study is prospective, randomized, double-blinded and controlled. A total of 60 subjects
will be randomly assigned to one of three treatment arms of the study: 20 subjects into the
1.5 atm abs oxygen equivalent HBO2 treatment, 20 subjects into the 2.0 atm abs oxygen
equivalent HBO2 treatment and 20 subjects into the sham treatment (a placebo exposure
equivalent to breathing atmospheric air). The protocol utilizes a pre- and post-treatment
comprehensive performance battery that will allow for meaningful clinical outcomes and a
broad understanding of the effects of the treatment. This project represents a collaboration
between the Department of Defense (DoD), the Richmond Veterans Administration Medical Center
(VAMC) and Virginia Commonwealth University. Service members will be recruited from military
bases/treatment facilities (MTF), receive hyperbaric oxygen at existing DoD hyperbaric
chambers and be evaluated by the established Virginia Commonwealth University-Center for
Rehabilitation Sciences and Engineering (CERSE), a collaborative research center co-located
at the Richmond VAMC and VCU.

Inclusion Criteria:

1. Post-Deployment status after having served in OIF/OEF

2. Blast Event within past 3 years during OIF/OEF deployment [event defined as any of
the following symptoms or experiences occurring during or shortly after the blast or
explosion: dazed, confused, saw stars, headache, dizziness, irritability, memory gap
(not remembering injury or injury period), hearing loss, abdominal pain, shortness of
breath, struck by debris, knocked over or down, knocked into or against something,
helmet damaged, evacuated]

3. Diagnosis of MTBI within 3 years as confirmed by the TBI specialty team at the
Richmond VAMC

4. Presence of post-concussive symptoms from MTBI, confirmed by the VCU-CERSE team at
the Richmond VAMC, for at least 3 months

5. Medical clearance to undergo hyperbaric oxygen treatment

6. Stable mental status for at least one month

7. Stable psychotropic medication history for at least one month

8. Ability to perform neuropsychologic testing battery

9. Ability to tolerate neurophysiological and neuroimaging battery

Exclusion Criteria:

1. Traumatic Brain Injury with a primary etiology other than blast

2. Moderate or Severe TBI (moderate or severe brain injury defined as best Glasgow Coma
Score in first 24 hours < 12, , brain bleeding or blood clot (i.e., abnormal brain CT
scan), or none of first week after event can be remembered.)

3. Past history of moderate or severe TBI

4. Active diagnosis of Post-traumatic Stress Disorder

5. Active diagnosis of Generalized Anxiety Disorder

6. Active Psychosis

7. Past history of Schizophrenia

8. Pre-existing PCS

9. Previous hyperbaric oxygen treatments

10. Contraindications to HBO2, including any "air trapping" pulmonary problems, inability
to equalize middle ear and sinuses, or patients who are claustrophobic and require
anti-anxiety medication for the condition

11. Active use of cancer medications

12. Pregnancy