Lay Interpretation of Preliminary Data in LSU IRB #7051 TBI/PTSD HBOT Pilot Trial:
 Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post-Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)-Pilot Trial

Paul G. Harch 1, Susan R. Andrews1, Edward Fogarty2, Juliette Lucarini1, Claire Aubrey1, Paul K. Staab1, Keith W. Van Meter1 1Louisiana State University School of Medicine, United States, 2University of North Dakota School of Medicine, United States 

The preliminary data from the LSU IRB #7051 TBI/PTSD HBOT Pilot Trial of Hyperbaric oxygen therapy in blast-induced chronic traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD) represents the first organized body of information that suggests a significant treatment effect on the conditions that present the greatest challenge to the integrity of our armed forces. The Rand Report of 1/2008 indicated that X% of our military that have served in Iraq and Afghanistan have been injured or affected by TBI or PTSD. Traditional treatment is protracted counseling and unapproved use of psychoactive drugs that have significant side effects such as increased suicide rates. Epidemic suicide rates in veterans are consistent with the use of such medications. In this seminal report at the 8th World Congress on Brain Injury Harch and colleagues from LSU School of Medicine, New Orleans demonstrated significant improvements in cognition, symptoms, and quality of life in 15 U.S. veterans with TBI and PTSD an average 3 years after their injury.

The physicians and researchers showed that with 4 weeks of treatment using a low dose of hyperbaric oxygen therapy, a treatment used for nearly 100 years in divers and 50 years for wounds, they were able to treat these wounds in the brains of injured U.S. servicemen. Specifically, the veterans achieved improvements in memory, concentration, executive function, and quality of life, and a reduction in headaches, concussion symptoms, depression, and anxiety. The average veteran experienced an increase in IQ of 15 points, a nearly 35 percentile increase. Other cognitive changes averaged 25 percentile point increases while quality of life measures, concussion symptoms, depression and anxiety indices, and the veterans' estimates of their cognitive, physical, and emotional improvements improved by 30-90%. Surprisingly, the veterans showed a 30% reduction in PTSD symptoms. While the study did not include a control group, the magnitude of the improvement measured was striking and never before reported in the medical literature. Moreover, the data was supported by functional imaging data and very similar to a previous study by Harch where HBOT improved memory and blood vessel density in an animal model of traumatic brain injury. Equally importantly, in both the case reports and the LSU pilot study there were no significant side effects to the treatment. The scientific report at the International Brain Injury Association's 8th World Congress reaffirmed earlier published peer-reviewed case reports of Harch and USAF Col. Jim Wright on brain injured U.S. servicemen.

The implication of this preliminary study is that U.S. veterans with the same conditions can safely begin treatment with this established modality, HBOT, by physician direction privately or under a national program approved by Western Institutional Review Board. This program, the National Brain Injury Recovery and Rehabilitation Project (N-BIRR) will incorporate the latest statistical design methodology that is favored by the FDA, the Bayesian Method, to accumulate further scientific proof of HBOT treatment for these two diagnoses. The program will consist of delivery of the same Harch HBOT protocol in one or two blocks; there will be no placebo group. The researchers hope to see this larger trial confirm the exciting preliminary results of the LSU pilot trial and the case reports.