Hyperbaric Oxygen Therapy in the Treatment of Chronic Mild-Moderate Blast-Induced Traumatic Brain Injury Post-Concussion Syndrome (PCS) and Post Traumatic Stress Disorder (PTSD)
Technical Report,30 Sep 2016,29 Sep 2017
Louisiana State University System New Orleans United States
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The purpose of the study is to see if an eight-week course of forty low-pressure HBOTs can significantly improve symptoms and cognitive function in military veterans and civilians with mild TBIPPCS. The proposed design is a randomized controlled non-treatment, non-sham single-arm crossover single-blind study. The scope of the project is to recruit, enroll, test, treat, re-test and follow-up on 50 subjects at Louisiana State University, New Orleans in 23 months and another 50 subjects at Oklahoma State University in an equivalent period of time. The study received final approval from all regulatory agencies on 5132014. Enrollment began shortly thereafter. By 9302017 150 subjects had been screened, 59 of the allotted 69 subjects had been enrolled, 8 of these had withdrawn prior to completing the post-8-week primary outcome testing, and another 4 withdrawals who did not complete the two-month post-treatment follow-up testing, leaving a total of 51 enrolled. 38 subjects have completed the protocol, 5 were in treatment at the end of September, 1 was in the control period, and 3 are in the two-month follow-up period post-hyperbaric oxygen treatment.
- Medicine and Medical Research
- Weapons Effects (Biological)