Clinical Trial: Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment of Moderate to Mild Cognitive Dysfunction Caused by Traumatic Brain Injury (TBI) With Hyperbaric Oxygen Therapy (HBOT)
Brief Summary: The purpose of this study is to determine if hyperbaric oxygen therapy (HBOT) improves the cognitive function of OIF/OEF individuals who have chronic mild to moderate traumatic brain injury (TBI). Cognitive function includes such things as thinking, remembering, recognition, concentration ability and perception. Traumatic brain injury is common with head injuries caused by blows to the head, nearby explosions, or concussion. Subjects will be assigned to an intervention or sham arm. Computer based cognitive tests will be used as outcome measures. Subjects are enrolled by invitation only.
Detailed Summary:
Sponsor: San Antonio Military Medical Center
Current Primary Outcome:
- Computer cognitive test scores [ Time Frame: six weeks post hyperbaric exposure series ]
- Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) scores [ Time Frame: six weeks post hyperbaric exposure series ]
Original Primary Outcome:
- Computer cognitive test scores [ Time Frame: Pre exposure, every 5 HBOT, six weeks post HBOT ]
- Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) scores [ Time Frame: pre exposure, every 5 HBOT, six weeks post HBOT ]
Current Secondary Outcome:
- Functional MRI [ Time Frame: six weeks post hyperbaric exposure series ]
- Biomarkers [ Time Frame: six weeks post hyperbaric exposure series ]
Original Secondary Outcome:
- Functional MRI [ Time Frame: pre exposure and six weeks post exposure ]
- Biomarkers [ Time Frame: pre exposure, after 15 HBOT, six weeks post HBOT ]
Information By: San Antonio Military Medical Center
Dates:
Date Received: December 17, 2008
Date Started: February 2009
Date Completion:
Last Updated: February 28, 2013
Last Verified: February 2013
