Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Louisiana State University |
---|---|
Information provided by: | Louisiana State University |
ClinicalTrials.gov Identifier: | NCT00760734 |
This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.
Condition | Intervention | Phase |
---|---|---|
TBI (Traumatic Brain Injury) Post Concussion Syndrome Post Traumatic Stress Disorder Chronic Post Traumatic Stress Disorder |
Drug: Low pressure hyperbaric oxygen therapy |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD) Pilot Trial |
Estimated Enrollment: | 30 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1-TBI (PCS): Experimental
Subjects with post-concussion syndrome at least one year after blast-induced mild-moderate traumatic brain injury will receive HBOT at 1.5 ATA/60 minutes twice/day, 5d/week for 40 or 80 treatments
|
Drug: Low pressure hyperbaric oxygen therapy
HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments
Drug: Low pressure hyperbaric oxygen therapy
HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments
|
2-TBI/PTSD: Experimental
Subjects with post-concussion syndrome and PTSD at least one year after blast-induced mild-moderate traumatic brain injury will receive HBOT at 1.5 ATA/60 minutes twice/day, 5d/week for 40 or 80 treatments
|
Drug: Low pressure hyperbaric oxygen therapy
HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments
Drug: Low pressure hyperbaric oxygen therapy
HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments
|
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Louisiana | |
LSU Health Sciences Center | Recruiting |
New Orleans, Louisiana, United States, 70112 | |
Contact: Paul G Harch, M.D. paulharchmd@aol.com | |
Contact: Juliette Lucarini, R.N> juliettelucarini@gmail.com | |
Principal Investigator: Paul G Harch, M.D. |
Principal Investigator: | Paul G Harch, M.D. | Louisiana State University |
Responsible Party: | Louisiana State University ( Paul G. Harch, M.D./Principal Investigator ) |
Study ID Numbers: | LSU IRB #7051 |
Study First Received: | September 25, 2008 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00760734 |
Health Authority: | United States: Institutional Review Board |
Chronic traumatic brain injury Post concussion syndrome Post traumatic stress disorder Chronic post traumatic stress disorder |
Craniocerebral Trauma Wounds and Injuries Head Injuries, Closed Stress Central Nervous System Diseases Disorders of Environmental Origin Trauma, Nervous System Brain Diseases |
Stress Disorders, Traumatic Brain Concussion Anxiety Disorders Mental Disorders Stress Disorders, Post-Traumatic Post-Concussion Syndrome Wounds, Nonpenetrating Brain Injuries |
Pathologic Processes Disease Syndrome Nervous System Diseases |