mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms (NCT01611194) | Clinical Trial Compass
CompletedPhase 2
mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms
United States71 participantsStarted 2012-09-11
Plain-language summary
Purpose of this study is to investigate the mechanisms of action of hyperbaric oxygen therapy for persistent post-concussive symptoms after mild tramatic brain injury
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.
Inclusion Criteria
* On active duty (TRICARE beneficiary) at the time of consent and through the 6-month visit or a Veteran, as well as Active Duty military who become Veterans after enrollment.
* Men and women 18-65 years of age at the time of study enrollment.
* Able to equalize middle ear pressure in a test of chamber pressure and tolerate the chamber environment.
* Able to speak and read English, as primary language.
* Agrees to and appears able to participate in all outcome assessments.
* Agrees to provide blood samples for clinical lab tests.
* Demonstrates the ability to offer informed consent and signs the study informed consent document.
* Participants stationed or living outside the Colorado Springs/Denver, Colorado area must be willing and able to travel. A reliable companion may accompany the participant if travel supervision is required.
* Active duty participants must obtain a letter of support from a supervisor or commanding officer prior to the outcome assessments (and travel, if necessary) to the OAC.
Participants must have a history of at least one (minimum requirement) mild traumatic brain injury (mTBI) with persistent symptoms that meets all the following criteria:
* Brain injury that occurred more than 3 months prior to baseline screening at the local site, with the most recent injury occurring no more than 5 years prior to randomization.
* Most recent traumatic brain injury (TBI) occurred on active duty.
* TBI was caused by non-penetrating trauma or b…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
Summary of Treatment-Emergent Adverse Events
Timeframe: months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months
2
Summary of Study Intervention-Related Adverse Events
Timeframe: months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months
Trial details
NCT IDNCT01611194
SponsorU.S. Army Medical Research and Development Command