Evidence map›Paper›PMID 41882764›Full record

ArticleTrials2026

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.

Dawn Neumann, Ambuj Kumar, Harry Van Loveren, USF HBOT for Veterans with TBI Collaborative Group

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06581003 (Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06581003 phase3recruitingnot on this map

Hyperbaric Oxygen Treatment for Veterans With Traumatic Brain Injury

TypeinterventionalSponsorUniversity of South FloridaRan2024 to 2029Enrolled420ConditionsTraumatic Brain Injury, Military OperationsArmsOxygen 99.7 %, Oxygen 21 %
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Dawn NeumannUniversity of South Florida, Morsani College of Medicine, USF Health Hyperbaric Oxygen Therapy Center, 13220 USF Laurel Drive, Tampa, FL, 33612, USA.
Ambuj KumarUniversity of South Florida, Morsani College of Medicine, 12901 Bruce B Downs Blvd, MDC 1152, Tampa, FL, 33612, USA. akumar6@usf.edu.ORCID http://orcid.org/0000-0003-1260-6694
Harry Van LoverenUniversity of South Florida, Morsani College of Medicine, USF Health Hyperbaric Oxygen Therapy Center, 13220 USF Laurel Drive, Tampa, FL, 33612, USA.
USF HBOT for Veterans with TBI Collaborative Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTraumatic 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.

methodsThis 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 registrationNCT06581003 (registered on 8/28/2024) https://clinicaltrials.gov/study/NCT06581003?term=NCT06581003&rank=1.

Indexed as

Brain Injuries, TraumaticHyperbaric OxygenationMilitary PersonnelVeteransEquivalence Trials as TopicHumansRandomized Controlled Trials as TopicResearch DesignTime FactorsTreatment OutcomeUnited StatesHyperbaric oxygen therapyNeurobehavioral symptomsPost-traumatic stressTraumatic brain injuryVeterans

Identifiers

PMID41882764
PMCPMC13137667

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.