USF’s clinical trial explores the potential benefits of hyperbaric oxygen therapy for Veterans & Active-Duty Service Members diagnosed with traumatic brain injury.
Overview
This randomized clinical trial tests whether HBOT can help reduce symptoms after traumatic brain injury compared to inactive (or placebo) HBOT. You may be eligible to participate in this trial if you meet the following criteria:
Condition
Mild or moderate traumatic brain injury or concussion exposure at least 1-year prior
Population
U.S. Service Member Veterans and Active-Duty Military. Age 18-75 years
Duration
Approximately 4 months
Information for Health Care Providers
This is a double-blind, sequential adaptive randomized controlled trial evaluating the impacts of 100% hyperbaric oxygen therapy administered at 2.0 atmosphere absolute (ATA) for 40 daily sessions. Inactive HBOT/Placebo group participants will receive 21% oxygen therapy in a non-pressurized hyperbaric oxygen chamber. Participants will be unblinded at two weeks after the last dive. Participants in the placebo group will be offered the chance to receive the active HBOT after their completion of 40 placebo/inactive sessions.
Information for Patients
Each participant will undergo a total of 40 HBOT dives over a span of 12 weeks. Each dive session takes approximately 90-minutes (~75 minutes in the HBOT chamber). Throughout the study, participants will be asked to complete questionnaires, complete brain games and give blood samples to test for markers of inflammation. Participants may also choose to participate in further testing.