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Background <p>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.</p> Methods <p>This is a single-center blinded group sequential superiority randomized controlled trial (RCT). All consecutive United&#xa0;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&#xa0;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%.</p> Discussion <p>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.</p> Trial registration <p>NCT06581003 (registered on 8/28/2024) <a href="https://clinicaltrials.gov/study/NCT06581003?term=NCT06581003&amp;rank=1">https://clinicaltrials.gov/study/NCT06581003?term=NCT06581003&amp;rank=1</a></p>

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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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月25日

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  • Dawn Neumann,
  • Ambuj Kumar,
  • Harry Van Loveren,
  • F Y Bowling,
  • Joseph Dituri,
  • Keith Dombrowski,
  • Rachel Karlnoski,
  • Kelli Kessack,
  • Jorge Mendoza,
  • Shannon R Miles,
  • Max Mokin,
  • Tea Reljic,
  • Paul Sanberg,
  • Nathan Schilaty,
  • Michael Schoenberg,
  • Mala Trivedi,
  • Athanasios Tsalatsanis,
  • Narayan Viswanadhan,
  • Alison Willing,
  • Chris Wilson,
  • Jason Wilson,
  • Hariom Yadav,
  • Fayyadh Yusuf

摘要

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