LSU IRB #7381
Welcome and thank you for your interest in the above study. The study is an investigation of hyperbaric oxygen therapy at 1.5 ATA (HBOT 1.5) in the treatment of mild traumatic brain injury (mTBI) persistent post-concussion syndrome (PPCS) resulting from either blunt or blast injury in both military and civilians. The study is to be conducted at Louisiana State University Health Sciences Center-New Orleans (LSUHSC-NO), and Oklahoma State University Health Sciences Center (OSUHSC) in Tulsa, Oklahoma. The OSU site is on hold pending funding. The LSU site is funded by a congressional appropriation that is administered through the U.S. Army at Fort Detrick, Maryland.
The study involves treatment of 50 subjects at LSUHSC-NO and 50 subjects at OSUHSC with HBOT 1.5 (HBOT at 1.5 ATA of pressure and oxygen) who have PPCS of 6 months to 10 years duration (a more detailed description of the study is posted on this website). The design is a randomized crossover design which means that subjects will be randomly assigned to either an HBOT 1.5 group (40 treatments over 8 weeks) or a control group which will continue any medication and counseling that they are currently receiving during the 8 week period that the HBOT group is receiving HBOT. Control group subjects will not have to remain in the New Orleans area for the eight week control group period. At the conclusion of the eight week period both the HBOT and control groups will have repeat testing. At the conclusion of testing, the control group will cross over to receive 40 HBOTs similar to the original HBOT group. In this way, all subjects in the study will receive 40 HBOTs. The control group will then undergo repeat testing. Six months after the last HBOT for each group all subjects will fill out a limited number of questionnaires which were part of the previous test batteries.
Paul G. Harch, M.D.