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| Sponsor: | International Hyperbaric Medical Foundation |
|---|---|
| Information provided by (Responsible Party): | B. Robert Mozayeni, 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| Contact: B Robert Mozayeni, MD | 800-288-9328 | callcenter@nbirr.org |
| United States, Arizona | |
| North Star Hyperbarics | Active, not recruiting |
| Tucson, Arizona, United States, 85741 | |
| United States, California | |
| Restorix Health - Loma Linda University Health Center | Active, not recruiting |
| Marietta, California, United States, 92563 | |
| San Francisco Institute for Hyperbaric Medicine | Active, not recruiting |
| San Francisco, California, United States, 94107 | |
| United States, Colorado | |
| Rocky Mountain Hyperbaric Institute | Active, not recruiting |
| Boulder, Colorado, United States, 80301 | |
| United States, Florida | |
| Hyperbaric Medicine Inc. of Florida | Active, not recruiting |
| Ft. Walton Beach, Florida, United States, 32547 | |
| United States, Minnesota | |
| Lifeforce Therapies | Active, not recruiting |
| Plymouth, Minnesota, United States, 55447 | |
| United States, Nevada | |
| Hyperbaric Institute of Nevada and Clinical Neurology Specialists | Recruiting |
| Henderson, Nevada, United States, 89012 | |
| Contact: Leo Germin, MD 702-804-1212 ext # DrG@cnsnevada.com | |
| Contact: John Dembo, CHT 702.450-8400 | |
| Principal Investigator: Leo Germin, MD | |
| United States, Ohio | |
| Alliance Community Hospital Wound Care and Hyperbaric Department | Not yet recruiting |
| Alliance, Ohio, United States, 44601 | |
| Contact: Melissa Loudon, RT, BBA 330-596-7940 mloudon@achosp.org | |
| Principal Investigator: Karen Gade-Pulido, MD | |
| United States, Oklahoma | |
| Oklahoma State University Center for Aerospace & Hyperbaric Medicine | Recruiting |
| Tulsa, Oklahoma, United States, 74132 | |
| Contact: LaDonna Lacey 918-586-4604 ladonna.lacey@okstate.edu | |
| Contact: Lisa Terry 918-382-3591 lisa.r.terry@okstate.edu | |
| Principal Investigator: Paul Rock, DO, PhD | |
| United States, Washington | |
| Restorix Health | Active, not recruiting |
| Issaquah, Washington, United States, 98027 | |
| United States, Wisconsin | |
| Fox Valley Wellness Center | Active, not recruiting |
| Fond du Lac, Wisconsin, United States, 54935 | |
| Study Director: | B Robert Mozayeni, MD | International Hyperbaric Medical Foundation |
| Study Chair: | Paul Harch, MD | International Hyperbaric Medical Foundation |
More Information
| Responsible Party: | B. Robert Mozayeni, MD, Study Director - NBIRR, VP Translational Medicine, 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: | March 4, 2012 |
| 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 |