NCT05643482

Hyperbaric Oxygen Therapy for Post-Concussion Syndrome

Completed NA Last updated 14 October 2025

What this trial tests

NA trial testing Hyperbaric Oxygen Treatment in Post-Concussion Syndrome in 12 participants. Completed in 12 May 2025.

Timeline

1 March 2023

Primary endpoint
12 May 2025

12 May 2025

Quick facts

Lead sponsor	University of Texas Southwestern Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	12
Start date	1 March 2023
Primary completion	12 May 2025
Estimated completion	12 May 2025
Sites	1 location across United States

Drugs / interventions tested

• Hyperbaric Oxygen Treatment — full drug profile →
• Placebo gas — full drug profile →

Conditions studied

• Post-Concussion Syndrome — all drugs for Post-Concussion Syndrome →

Sponsor

University of Texas Southwestern Medical Center

Who can join

Adults 18 to 65, any sex, with Post-Concussion Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to decrease symptom burden, improve cognitive function, and improve quality of life outcomes in subjects with mild TBI and persisting post-concussion syndrome using Hyperbaric Oxygen Treatment compared to a sham intervention.

Specific Aims:

1. Evaluate the efficacy of hyperbaric oxygen treatment to improve outcomes for adults with persisting post-concussion syndrome. Specifically, the investigators hypothesize that a prescribed course of hyperbaric oxygen treatments (HBOT) will improve outcomes and quality of life in adults with persisting symptoms \>3 months after injury.

1. Decrease symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire (RPQ).
2. Improve cognitive function as measured by the National Institutes of Health (NIH) Toolbox Cognition Battery.
3. Improve quality of life as measured by the 36-Item Short Form Survey (SF-36).
2. Assess the safety and tolerability of hyperbaric oxygen treatments and compliance with treatment in adults with persisting post-concussion syndrome.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hyperbaric Oxygen Therapy versus placebo for post-concussion syndrome (HOT-POCS): A randomized, double-blinded controlled pilot study.
   Wright B, Guilliod R, Thakur B, Kundig C, et al · · 2023 · cited 2× · PMID 37416626 · DOI 10.1016/j.conctc.2023.101176