Hyperbaric Oxygen Therapy versus placebo for post-concussion syndrome (HOT-POCS): A randomized, double-blinded...

Post-Concussion Syndrome (PCS) refers to the persistence of physical, cognitive, and emotional symptoms following mild traumatic brain injury (mTBI)/concussion, occurring in roughly 15-30% of individuals. Hyperbaric oxygen therapy (HBOT) has been suggested as a potential treatment for PCS; however, the evidence to date is mixed due to inconsistencies in the treatment protocol and focus on veterans with combat-related injuries, which may not be generalizable to the general population. The goal of Hyperbaric Oxygen Therapy for Post-Concussion Syndrome (HOT-POCS) is to assess the efficacy and safety of HBOT for the treatment of PCS in the civilian population. This randomized, controlled pilot study will be using a standardized HBOT protocol (20 sessions of 100% O₂ at 2.0 atm absolute [ATA]) compared with a true placebo gas system that mimics the oxygen composition at room air (20 sessions of 10.5% O₂ and 89.5% nitrogen at 2.0 ATA) in a cohort of 100 adults with persistent post-concussive symptoms 3-12 months following injury. Change in symptoms on the Rivermead Post-concussion Questionnaire (RPQ) will be the primary outcome of interest. Secondary outcomes include the rate of adverse events, change in the quality of life, and change in cognitive function. Exploratory outcome measures will include changes in physical function and changes in cerebral brain perfusion and oxygen metabolism on MRI brain imaging. Overall, the HOT-POCS study will compare the efficacy of a standardized HBOT treatment protocol against a true placebo gas for the treatment of PCS within 12 months after injury.