Hyperbaric Oxygen Therapy for Post-Concussion Syndrome
United States12 participantsStarted 2023-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Pulmonary:
. Cardiac:
. Hematological/Oncological:
. Neurological and Psychological:
. Head and Neck:
. Miscellaneous:
. Relative exclusion criteria: Diagnosis of the conditions listed below will require approval of the hyperbaric medicine physician for enrollment into the study.
. Medications: Individuals with recent (within the past six months) or concurrent use of these medications must be approved by the hyperbaric medicine physician.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial on hyperbaric oxygen therapy for post-concussion syndrome has been completed — has the results data been published yet, and if so, what did it show about changes in symptoms on the Rivermead questionnaire?
2Since this study is listed as 'Phase NA,' meaning it's not a standard drug trial with the usual phase-based safety testing, what does that tell us about how well-established the safety profile of hyperbaric oxygen therapy is for post-concussion syndrome?
3The trial measured symptom burden using the Rivermead Post-Concussion Symptoms Questionnaire — based on what's been found, are the kinds of symptoms it tracks, like headaches and cognitive difficulties, similar to what I'm experiencing, and would that make this relevant to my situation?
4Are there standard treatments for post-concussion syndrome I should try first before considering something like hyperbaric oxygen therapy, especially given that this research is still relatively new?
5Hyperbaric oxygen therapy requires sitting in a pressurized chamber for multiple sessions — given my overall health and schedule, is this kind of treatment commitment something my care team would even consider appropriate for me to explore?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
Timeframe: Baseline, immediately after treatment
2
Change in symptom burden as measured by the Rivermead Post-Concussion Symptoms Questionnaire-3 (RPQ-3)
Timeframe: Baseline, 1 month after treatment
Trial details
NCT IDNCT05643482
SponsorUniversity of Texas Southwestern Medical Center