Clinical Trial: mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Brain Injury and Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms After Mild Traumatic Brain Injury (BIMA) Protocol
Brief 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
Detailed Summary:
Sponsor: U.S. Army Medical Research and Materiel Command
Current Primary Outcome: Battery of symptom and quality of life assessments [ Time Frame: 4 years ]
Original Primary Outcome: Change from baseline at 13 weeks and 6 months of neuropsychiatric measures [ Time Frame: 12 months, 40 HBO2 sessions ]
Current Secondary Outcome:
Original Secondary Outcome: compare rates of change in neuropsychiatric measure between treatment and sham [ Time Frame: 12 months ]
- To evaluate safety of the proposed hyperbaric oxygen versus sham interventions
- To identify practical issues in instituting assessments among participants with PCS and to address related logistical considerations prior to initiating the pivotal study.
- To compare outcome assessment results to a normative population, without history of traumatic brain injury (TBI), comprehensively assessed in a similar fashion in a companion study.
Information By: U.S. Army Medical Research and Materiel Command
Dates:
Date Received: May 3, 2012
Date Started: September 2012
Date Completion: January 2018
Last Updated: May 2, 2017
Last Verified: May 2017