Hyperbaric Oxygen Therapy in the Treatment of Chronic Mild-Moderate Blast-Induced Traumatic Brain Injury PCS and PTSD
Annual rept. 30 Sep 2011-29 Sep 2012
LOUISIANA STATE UNIV NEW ORLEANS
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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 TBIPCS 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. Pre-IND meeting was held with the FDA on 3122012. Recommendations were made regarding change in study design, screening, and outcome instruments for a study whose results, if positive, would be suitable for a new pre-market FDA application. These recommendations prompted sourcing for additional funding and partner sites. An additional site has been recruited and administrative organizational meetings held to secure funding for the additional site. A final protocol will be agreed upon in the next week and the IND application prepared for submission.
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