Post-Concussion Syndrome Clinical Trial
Official title:
Brain Injury and Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms After Mild Traumatic Brain Injury (BIMA) Protocol
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
Active duty military personnel and Veterans received for 60-minute daily chamber sessions in
which they received HBO2, 1.5 atmospheres absolute (ATA), or sham intervention (1.2 ATA, room
air) for post concussion syndrome (PCS).
The study is to provide a rationale for the selection of outcome assessments to serve as
primary and secondary endpoints for a pivotal randomized clinical 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.
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