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| Sponsor: | International Hyperbaric Medical Foundation |
|---|---|
| Information provided by (Responsible Party): | James Wright, MD, International Hyperbaric Medical Foundation |
| ClinicalTrials.gov Identifier: | NCT01105962 |
Purpose
This is an observational research study whose purposes are to see:
| Condition |
|---|
|
Traumatic Brain Injury Post-traumatic Stress Disorder |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Multicenter Observational Study of Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post-Concussion Syndrome (PCS) and/or TBI/Post-Traumatic Stress Disorder (PTSD) |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
One thousand subjects will be recruited. Subjects will be 18-65 years old and have been diagnosed with mild or moderate (but not severe) TBI or TBI/PTSD or PTSD by either the military (any etiology) or civilian neurologists or neuropsychologists. This diagnosis will especially include war veterans who have had a significant decrease in their neuropsychological test scores.
There will be no gender restriction. However, it is anticipated that the cohort will consist mostly of males, due to the nature of the injury. There will be no race or ethnicity restriction.
All subjects will be legally capable of consenting. No subjects who need 3rd party consent will be enrolled in the NBIRR study.
Military - Unless specifically approved by a military site IRB, active duty participants will have to voluntarily contact NBIRR participating sites or respond to a recruitment outreach outside of the command.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Arizona | |
| North Star Hyperbarics | |
| Tucson, Arizona, United States, 85741 | |
| United States, California | |
| Restorix Health - Loma Linda University Health Center | |
| Marietta, California, United States, 92563 | |
| San Francisco Institute for Hyperbaric Medicine | |
| San Francisco, California, United States, 94107 | |
| United States, Colorado | |
| Rocky Mountain Hyperbaric Institute | |
| Boulder, Colorado, United States, 80301 | |
| United States, Florida | |
| Hyperbaric Medicine Inc. of Florida | |
| Ft. Walton Beach, Florida, United States, 32547 | |
| United States, Minnesota | |
| Lifeforce Therapies | |
| Plymouth, Minnesota, United States, 55447 | |
| United States, Nevada | |
| Hyperbaric Institute of Nevada and Clinical Neurology Specialists | |
| Henderson, Nevada, United States, 89012 | |
| United States, Oklahoma | |
| Oklahoma State University Center for Aerospace & Hyperbaric Medicine | |
| Tulsa, Oklahoma, United States, 74132 | |
| United States, Washington | |
| Restorix Health | |
| Issaquah, Washington, United States, 98027 | |
| United States, Wisconsin | |
| Fox Valley Wellness Center | |
| Fond du Lac, Wisconsin, United States, 54935 | |
| Study Chair: | Paul G Harch, MD | International Hyperbaric Medical Foundation |
| Study Director: | James Wright, MD | International Hyperbaric Medical Foundation |
More Information
| Responsible Party: | James Wright, MD, Principal Investigator - NBIRR, VP Research, International Hyperbaric Medical Foundation., International Hyperbaric Medical Foundation |
| ClinicalTrials.gov Identifier: | NCT01105962 History of Changes |
| Other Study ID Numbers: | NBIRR-01 |
| Study First Received: | April 15, 2010 |
| Last Updated: | September 13, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
traumatic brain injury post-traumatic stress |
hyperbaric oxygen HBOT TBI PTSD |
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Brain Injuries Post-Concussion Syndrome Anxiety Disorders Mental Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Brain Concussion Head Injuries, Closed Wounds, Nonpenetrating |