new regulatory requirements will require funding for restart as a new study
NBIRR-1
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)
Sponsor study identifier
observational
133
1 country
10
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)This is an observational research study whose purposes are to see:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 15, 2010
Actual (reported)April 19, 2010
Actual (reported)May 2010
Date type not reportedThis date has not been verified as actual or estimated.
March 2015
Actual (reported)March 2015
Actual (reported)Cognitive Function
2-6mo then every 6 months for 2yrs
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.
San Francisco Institute for Hyperbaric Medicine
San Francisco, California, 94107, United States
Rocky Mountain Hyperbaric Institute
Boulder, Colorado, 80301, United States
Hyperbaric Services of the Palm Beaches
Delray Beach, Florida, 33484, United States
Hyperbaric Medicine Inc. of Florida
Fort Walton Beach, Florida, 32547, United States
Idaho Wound Care & Hyperbaric Medicine
Pocatello, Idaho, 83201, United States
Lifeforce Therapies
Plymouth, Minnesota, 55447, United States
Hyperbaric Institute of Nevada and Clinical Neurology Specialists
B Robert Mozayeni, MD
International Hyperbaric Medical Foundation
133 participants (actual enrollment reported by the registry).
First Submitted
April 15, 2010
First Posted
April 19, 2010
Study Start
May 2010
Date type not reportedThis date has not been verified as actual or estimated.
Cognitive REmediation After Trauma Exposure Trial = CREATE Trial
Contact the study team to confirm eligibility.
Henderson, Nevada, 89012, United States
Alliance Community Hospital Wound Care and Hyperbaric Department
Alliance, Ohio, 44601, United States
HBOT NOVA - Hyperbaric Oxygen Therapy of Northern Virginia
Reston, Virginia, 20190, United States
Fox Valley Wellness Center
Fond du Lac, Wisconsin, 54935, United States
Primary Completion
March 2015
Actual (reported)Study Completion
March 2015
Actual (reported)Last Updated
September 20, 2016
Record last verified: 2016-09
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Source: ClinicalTrials.gov.
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