Hyperbaric Oxygen Therapy Clinical Trial (Army)
Abstract
For the Army, the Hyperbaric Oxygen Therapy (HBO2) clinical trials focus on research related to the development of treatment modalities using HBO2 for chronic post-concussion syndrome after mild traumatic brain injury (mTBI). Three HBO2 human clinical trials were designed to evaluate the effectiveness of HBO2 treatments for Service members who have experienced one or more concussions and who are symptomatic at, or after, the time of post-deployment health reassessments: 1- A pilot phase II (narrow population safety and effectiveness) study of hyperbaric oxygen for persistent post-concussive symptoms after mild traumatic brain injury (HOPPS), 2- Brain Injury and Mechanisms of Action of Hyperbaric Oxygen for Persistent Post-Concussive Symptoms after Mild Traumatic Brain Injury (BIMA), and 3- Development of Normative Datasets for Assessments Planned for Use in Patients with Mild Traumatic Brain Injury (Normal). A fourth retrospective study, Long Term Follow-up (LTFU), is focused on the lessons learned from long-term follow-up of subjects enrolled in the Department of Defense (DoD) primary HBO2 trials. To support these protocols, four HBO2 study sites were established within the Military Health System. Each of the research sites consisted of a hyperbaric oxygen chamber enclosed in a mobile trailer, a second mobile trailer for testing and evaluation of the subjects, and a third subject staging trailer. This information is intended to inform DoD policy decisions regarding the use of HBO2 therapy as a treatment for mTBI.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2019
- Source ID
- 399A_0605145DHA_2_0130_PB_2019
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