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| Name | Class |
|---|---|
| Semper Fi Fund | UNKNOWN |
| Marine Corps-Law Enforcement Foundation | OTHER |
| Coalition to Support America's Heroes | UNKNOWN |
| Thirty-eight other contributors |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperbaric oxygen therapy-TBI/PCS | Experimental | Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT |
|
| Hyperbaric Oxygen Therapy-PCS/PTSD | Experimental | Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low pressure hyperbaric oxygen therapy | Drug | HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Psychometric testing | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| SPECT brain imaging | 30 days | |
| Quality of life measurements | 30 days | |
| Return to school or work |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul G Harch, M.D. | Louisiana State University Health Sciences Center in New Orleans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LSU Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22026588 | Result | Harch PG, Andrews SR, Fogarty EF, Amen D, Pezzullo JC, Lucarini J, Aubrey C, Taylor DV, Staab PK, Van Meter KW. A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder. J Neurotrauma. 2012 Jan 1;29(1):168-85. doi: 10.1089/neu.2011.1895. Epub 2011 Nov 22. |
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| UNKNOWN |
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|
| Low pressure hyperbaric oxygen therapy | Drug | HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments |
|
|
| 6 months |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D038223 | Post-Concussion Syndrome |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D001924 | Brain Concussion |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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