mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms (BIMA)
|ClinicalTrials.gov Identifier: NCT01611194|
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : October 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury With Brief Loss of Consciousness Post-Concussion Syndrome||Drug: Hyperbaric oxygen (HBO2) at 1.5 atms Drug: Sham control 1.2 atms||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Brain Injury and Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms After Mild Traumatic Brain Injury (BIMA) Protocol|
|Actual Study Start Date :||September 11, 2012|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 29, 2016|
Experimental: Active group (HBO2)
Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized.
Drug: Hyperbaric oxygen (HBO2) at 1.5 atms
The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.
Sham Comparator: Sham control
Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).
Drug: Sham control 1.2 atms
The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611194
|United States, Colorado|
|Outcomes Assessment Center, Evans Army Community Hospital|
|Colorado Springs, Colorado, United States, 80913|
|Evans Army Community Hospital / Hyperbaric Medicine Complex|
|Fort Carson, Colorado, United States, 80913|
|United States, North Carolina|
|Jacksonville, North Carolina, United States, 28542|
|United States, Washington|
|Joint Base Lewis-McChord|
|Fort Lewis, Washington, United States, 98438|
|TBI Program/HBO2 Research Program Madigan Healthcare system|
|Tacoma, Washington, United States, 98431|
|Principal Investigator:||Lindell Weaver, MD||Intermountain Health Care, Inc.|