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Hyperbaric Oxygen Therapy for Post-Concussion Syndrome

NCT05643482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-10-14

No results posted yet for this study

Summary

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.

Conditions

  • Post-Concussion Syndrome

Interventions

DEVICE

Hyperbaric Oxygen Treatment

Pressurization at 2.0 ATA with 100% oxygen

OTHER

Placebo gas

Pressurization at 2.0 ATA with 10.5% oxygen to mimic normal air

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • James Berry, M.D. · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2025-05-12
Completion
2025-05-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05643482 on ClinicalTrials.gov