Hyperbaric Oxygen Therapy in the Treatment of Chronic Mild-Moderate Blast-Induced Traumatic Brain Injury PCS and PTSD
Technical Report,30 Sep 2014,29 Sep 2015
LOUISIANA STATE UNIVERSITY 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 controllednon-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 By 9302015 88 subjects had been screened, 29 subjects have been enrolled, and five of these have withdrawn, leaving a total of 24 enrolled. Twelve subjects have completed the protocol. Four were in treatment at the end of September, one was in the control period, and 7 are in the two-month follow-up period post-hyperbaric oxygen treatment. Four additional subjects have been screened in October 2015 and nine are awaiting first appointment for enrollment. 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. The study is on temporary hold due to an interim review by the LSUHSC-NO IRB. The review has been completed and it is expected the hold will be released in November 2015.