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 ]

The primary objective of this randomized study is to provide a rationale for the selection of outcome assessments to serve as primary and secondary endpoints for a pivotal randomizedclinical trial of hyperbaric oxygen for the treatment of PCS. The participants will undergo a comprehensive battery of symptom and quality of life assessments. The distribution of response, change in response over time, homogeneity of variance across subgroups, and relationships between outcome measures will be compared by treatment assignment with a cohort from a study of similar design among a normal study population.


Original Primary Outcome: Change from baseline at 13 weeks and 6 months of neuropsychiatric measures [ Time Frame: 12 months, 40 HBO2 sessions ]

Additionally, this study will describe the brain function and anatomy of active duty personnel with PCS who are symptomatic at least 3 months but no more than 5 years after mild traumatic brain injury using a comprehensive battery of assessments, across time, in groups randomized to receive intervention (hyperbaric oxygen) or sham control, and explore potential associations between changes in function, anatomy, and participant reported outcomes.


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