Hyperbaric Oxygen Therapy in the Treatment of Chronic Mild-Moderate Blast-Induced Traumatic Brain Injury PCS and PTSD

摘要

The purpose of the study is to see if a four-week course of forty low-pressure HBOT s can significantly improve symptoms and cognitive function in military veterans with mild-moderate blast-induced TBI/PCS with PTSD. The scope of the project is to recruit, enroll, treat, and test 50 subjects in a randomized controlled double-blind study within 18 months. There are no results to report at this time since the study has not begun. The study is still in the pre-enrollment regulatory process. An FDA IND was granted on 10/24/2013. A decision on a Special Protocol Assessment (SPA) application attached to this IND is due by November 10, 2013. The SPA decision will determine the final protocol that will be allowed for this study. The study will commence shortly thereafter.