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Sponsored by: |
San Antonio Military Medical Center |
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Information provided by: | San Antonio Military Medical Center |
ClinicalTrials.gov Identifier: | NCT00810615 |
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.
Condition | Intervention | Phase |
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Brain Injury, Chronic |
Other: Hyperbaric oxygen @ 2.4 ATA |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
Official Title: | Treatment of Moderate to Mild Cognitive Dysfunction Caused by Traumatic Brain Injury (TBI) With Hyperbaric Oxygen Therapy (HBOT) |
Estimated Enrollment: | 50 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Sham treatment: Sham Comparator
Subject will breath air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
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Other: Hyperbaric oxygen @ 2.4 ATA
Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
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Hyperbaric oxygen 2.4 ATA: Experimental
Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
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Other: Hyperbaric oxygen @ 2.4 ATA
Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
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Ages Eligible for Study: | 19 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Chair: | Robert S. Michaelson, D.O. | SAMMC Hyperbaric Center |
Study Director: | E. George Wolf, M.D. | SAMMC Hyperbaric Center |
Principal Investigator: | Jason J. Cho, M.D. | SAMMC Hyperbaric Center |
Responsible Party: | SAMMC Hyperbaric Center ( Col Robert Michaelson ) |
Study ID Numbers: | FWH20080137H |
Study First Received: | December 17, 2008 |
Last Updated: | December 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00810615 History of Changes |
Health Authority: | United States: Federal Government |
chronic TBI cognitive function PTSD HBO |
hyperbaric oxygen chronic brain injury |
Craniocerebral Trauma Brain Damage, Chronic Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases |
Trauma, Nervous System Brain Diseases Brain Injuries Brain Injury, Chronic |
Craniocerebral Trauma Brain Damage, Chronic Nervous System Diseases Wounds and Injuries Disorders of Environmental Origin |
Central Nervous System Diseases Trauma, Nervous System Brain Diseases Brain Injuries Brain Injury, Chronic |