Louisiana State University Health Sciences Center-N.O. New Orleans United States
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 By 9302016 124 subjects had been screened, 46 of the allotted 50 subjects have been enrolled, and 10 of these have withdrawn, leaving a total of 36 enrolled. 27 subjects have completed the protocol. 1 was in treatment at the end of September, 3 were in the control period, and 5 are in the two-month follow-up period post-hyperbaric oxygen treatment. 1 additional subject is scheduled to be screened in October 2016 and 3 are awaiting first appointment for enrollment. A total of 17 subjects have been enrolled in the past year since the previous annual report. Due to the dropoutwithdrawals the study enrollment limit was increased from 50 to 59. At the current pace of recruitment a No Cost Extension will be necessary to complete the study. The second site for the study, Oklahoma State University Center for Health Sciences, has not participated in the study due to inability to secure funding. There are no study results to report at this time and no significant adverse advents.