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 range18 Years – 65 Years
SexALL
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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…
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