Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury

Summary

The goal of this blinded, adaptive, randomized, placebo-controlled clinical trial is to investigate the use of hyperbaric oxygen as a therapy to treat mild to moderate traumatic brain injury in Veterans and active military. The main questions it aims to answer are: * Does Hyperbaric Oxygen Therapy (HBOT) reduce neurobehavioral symptoms? (Aim 1) * How many HBOT sessions are needed to achieve a significant reduction in neurobehavioral symptoms? (Aim 2) * Does HBOT reduce posttraumatic stress disorder (PTSD) symptoms? (Aim 3) Exploratory objectives will explore if there are changes in: 1.) cognitive functioning using neuropsychological tests and the National Institutes of Health (NIH) toolbox, 2.) inflammation biomarkers in blood, 3.) microbiome in stool samples, 4.) electroencephalogram (EEG), 5.) sleep characteristics, and 6.) fMRI. Research will compare HBOT therapy to a placebo condition to see if HBOT works to treat neurobehavioral symptoms. The placebo condition is a chamber that remains unpressurized and has 21% oxygen. Participants will: 1. Complete baseline assessments to determine eligibility. 2. Attend 40 sessions of HBOT or placebo (normal air) within 12 weeks. 3. Complete questionnaires and interviews throughout the course of the study. 4. Complete a 2-week post treatment visit

Timeline

Start

2024-09-18

Primary completion

2028-08-15

Completion

2029-08-15

Publications

• Background Ajayi OD, Gaskill Z, Kelly M, Logue CJ, Hendricksen SM. A comparison of two hyperbaric oxygen regimens: 2.0 ATA for 120 minutes to 2.4 ATA for 90 minutes in treating radiation-induced cystitis Are these regimens equivalent? Undersea Hyperb Med. 2020 Fourth Quarter;47(4):581-589. doi: 10.22462/10.12.2020.7.
• Background Daly S, Thorpe M, Rockswold S, Hubbard M, Bergman T, Samadani U, Rockswold G. Hyperbaric Oxygen Therapy in the Treatment of Acute Severe Traumatic Brain Injury: A Systematic Review. J Neurotrauma. 2018 Feb 15;35(4):623-629. doi: 10.1089/neu.2017.5225. Epub 2018 Jan 22.
• Background Loignon A, Ouellet MC, Belleville G. A Systematic Review and Meta-analysis on PTSD Following TBI Among Military/Veteran and Civilian Populations. J Head Trauma Rehabil. 2020 Jan/Feb;35(1):E21-E35. doi: 10.1097/HTR.0000000000000514.
• Neumann D, Kumar A, Van Loveren H; USF HBOT for Veterans with TBI Collaborative Group. Efficacy of hyperbaric oxygen treatment in veterans and service members with traumatic brain injury-a study protocol for a blinded three-stage group sequential randomized controlled trial. Trials. 2026 Mar 25;27(1):352. doi: 10.1186/s13063-026-09645-z.
• Walters KF, Templeton JM, van Loveren H, Yusuf FR, Schilaty ND. EEG as a diagnostic tool and therapeutic monitor in traumatic brain injury: a sub-study methodology from the hyperbaric oxygen treatment for veterans with traumatic brain injury randomized controlled trial. Trials. 2026 Feb 16;27(1):227. doi: 10.1186/s13063-026-09531-8.

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Indications