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)
Abstract
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 TBI/PPCS. 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 5/13/2014. Enrollment began shortly thereafter. By 9/30/2017 150 subjects had been screened, 59 of the allotted 69 subjects had been enrolled, 8 of these had withdrawn prior to completing the post-8-week primary outcome testing, and another 4 withdrawals who did not complete the two-month post-treatment follow-up testing,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.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2017
- Accession Number
- AD1048777
Entities
People
- Paul G. Harch
Organizations
- Louisiana State University System