Hyperbaric Oxygen Treatment to Treat Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)

This is a randomized prospective controlled single-blind crossover clinical trial of 1.5 ATA
(atmospheres absolute) HBOT versus maintenance medication and counseling. One hundred adult
subjects (50 at Louisiana State University Health Sciences Center-New Orleans and 50 at
Oklahoma State University School of Medicine) with mTBI/PPCS who have been symptomatic
continuously for at least six months from one or more mild traumatic brain injuries will be
enrolled and randomized to either 40 HBOTs or no treatment. After the 8-week treatment
period the no treatment group will be crossed over to receive 40 HBOTs.

Inclusion Criteria:

1. Adults, 18-65 years old.

2. One or more mild TBI's due to blunt or blast injury.

3. Meets criteria for PPCS.

4. Ability to complete the NSI.

5. Ability to complete the PCL-M or C.

6. Ability to complete CAPS if needed.

7. Absence of acute cardiac arrest or hemorrhagic shock at time of TBI that would cause
a global ischemic insult to the TBI.

8. Ability to complete the Michigan Alcohol Screening Test( MAST) and Drug Abuse
Screening Test (DAST).

9. Ability to complete a urine toxicology screen for drugs of abuse.

10. Negative pregnancy test in females. Female subjects will need to have a negative
urinalysis result in order to start or continue treatment.

11. Subjects must be legally responsible, speak and understand English fluently, and be
able to sign their own consent documents.

12. Otherwise good health.

Exclusion Criteria:

1. Pulmonary disease that precludes HBOT (e.g., bronchospasm unresponsive to medication,
bullous emphysema).

2. Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive
heart failure or heart failure requiring hospital emergency evaluation or admission
in the previous year).

3. Severe confinement anxiety (e.g., patients who require anesthesia conscious sedation
for MRI).

4. Other pre-TBI cerebral neurological diagnoses including stroke, dementia,
degenerative diseases, multiple sclerosis, congenital neurological disorder.

5. Participation in another experimental trial with active intervention.

6. High probability of inability to complete the experimental protocol (e.g. terminal
condition or inability to complete outcome instruments).

7. Previous HBOT.

8. History of hospitalization for past stroke, non-febrile seizures, or any seizure
history other than seizure at the time of TBI.

9. Past or current history of mental retardation.

10. Pre-/post-TBI history of systemic illness with impact on central nervous system
(P.I.'s decision).

11. Pre-injury psychiatric disorders for which the patient was on medication at the time
of the brain injury responsible for the patient's diagnosis of TBI/PPCS.

12. Any concurrent systemic illness whose symptomatology confounds the diagnosis of PPCS
(P.I.'s decision).

13. Active malignancy undergoing treatment.

14. Taking lithium.