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Efficacy of hyperbaric oxygen treatment in veterans and service members with traumatic brain injury-a study protocol
Dawn Neumann1, Ambuj Kumar2, Harry Van Loveren1
1University of South Florida, Morsani College of Medicine, USF Health Hyperbaric Oxygen Therapy Center, 13220 USF Laurel Drive, Tampa, FL, 33612, USA.
Background:
Traumatic brain injury (TBI) is common amongst Veterans and Military Service Members (V/SM), with 510,000 diagnosed with a TBI between 2000 and 2024, of which 82% were mild and 12% moderate. Hyperbaric oxygen therapy (HBOT) is considered a potential intervention for the management of mild/moderate TBI. However, the results from previous randomized controlled trials (RCTs) assessing the efficacy of HBOT for managing mild/moderate TBI are inconclusive due to several reasons, including lack of a priori power analyses, design considerations, and inappropriate comparators. The primary objective of this study is to assess the efficacy of HBOT compared to placebo/sham in reducing chronic neurobehavioral symptoms in participants with chronic mild to moderate TBI.
Methods:
This is a single-center blinded group sequential superiority randomized controlled trial (RCT). All consecutive United States (USA) V/SM with a history of mild or moderate TBI with persistent neurobehavioral symptoms (≥ 22 on the Neurobehavioral Symptom Inventory) at a year or more post-injury will be eligible for inclusion. HBOT medical grade oxygen pressurized to 2.0 Atmospheres Absolute (ATA) with Sechrist 3600H/HR monoplace hyperbaric chambers will be compared to a sham group of 1.0 ATA (normobaric) with oxygen delivered at 21% (normal oxygen concentration in room air) for approximately 60 min. The primary outcome is the post-intervention Neurobehavioral Symptom Inventory (NSI) score. Secondary outcomes are the number of HBOT dives needed to achieve a reduction in NSI score and to assess the impact of HBOT on post-traumatic stress disorder (PTSD) symptoms using the PTSD Checklist for DSM-5 (PCL-5). The study aims to enroll 420 subjects with an expected dropout rate of 20%.
Discussion:
The study will determine the efficacy of HBOT at 2.0 ATA in reducing long-term neurobehavioral symptoms in V/SM with histories of mild to moderate TBI. This information will assist participants, providers, and policy members in managing chronic neurobehavioral symptoms after TBI.
Trial Registration:
NCT06581003 (registered on 8/28/2024) https://clinicaltrials.gov/study/NCT06581003?term=NCT06581003&rank=1.
