Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or Post-Traumatic Stress Disorder (NBIRR-1)

This study has suspended participant recruitment.
(recent new general guidance from FDA prompted IRB to suspend study temporarily pending clarification of regulatory status)
Sponsor:
Information provided by (Responsible Party):
International Hyperbaric Medical Foundation
ClinicalTrials.gov Identifier:
NCT01105962
First received: April 15, 2010
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

This is an observational research study whose purposes are to see:

  1. if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or 80 HBOT's) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress Disorder).
  2. if improvements or worsening of symptoms can be recorded with computerized and written tests for memory and thinking, and with questionnaires about the subject's quality of life and health.
  3. determine the long-term outcome of the treatment.
  4. confirm, in large numbers of study participants at multiple sites nationwide, the strong positive results obtained in pilot studies

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)

Resource links provided by NLM:


Further study details as provided by International Hyperbaric Medical Foundation:

Primary Outcome Measures:
  • Cognitive Function [ Time Frame: 2-6mo then every 6 months for 2yrs ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: May 2010
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  1. Any 18-65 year-old patient with mild-moderate TBI or PTSD. (If a military injury, subject may be active duty or a veteran. If active duty, participants will have to voluntarily contact NBIRR.)
  2. Have demonstrated a >20% decrement (compared to pre-deployment baseline) in ANAM composite score or specific sub-score with regard to "simple reaction time" and/or "procedural reaction time".
  3. Have a diagnosis of TBI, chronic TBI/PCS or TBI/PCS/PTSD or PTSD made by a military (military etiology of blast injury) or civilian specialist.
  4. Negative pregnancy test in females.
  5. Less than 90% on the Percent Back to Normal Rating Scale. (If patient is considered 100% normal before TBI, patient should be less than 90% normal for entry into the study).

Exclusion Criteria:

  1. Pulmonary disease that precludes HBOT (e.g., asthma unresponsive to medication, bullous emphysema).
  2. Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year).
  3. Severe confinement anxiety (claustrophobia; e.g., patients who require anesthesia conscious sedation for MRI or who cannot go in elevators).
  4. Pregnancy.
  5. Other pre-TBI neurological diagnoses.(seizure disorders, multiple sclerosis, Parkinson's, Lyme, etc.)
  6. Participation in another experimental trial with active intervention.
  7. High probability of inability to complete the experimental protocol (e.g. terminal condition).
  8. Past or current history of mental retardation unless diagnosed post TBI (baseline IQ ≤ 70).
  9. Pre- or post-TBI history of systemic illness with impact on central nervous system. (Principal Investigator in consultation with study sponsor Medical Officer will make the ultimate decision).
  10. Any pre-existing chronic infection not related to battlefield injuries or government service.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105962

Locations
United States, California
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 Services of the Palm Beaches
Del Ray Beach, Florida, United States, 33484
Hyperbaric Medicine Inc. of Florida
Ft. Walton Beach, Florida, United States, 32547
United States, Idaho
Idaho Wound Care & Hyperbaric Medicine
Pocatello, Idaho, United States, 83201
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, Ohio
Alliance Community Hospital Wound Care and Hyperbaric Department
Alliance, Ohio, United States, 44601
United States, Virginia
HBOT NOVA - Hyperbaric Oxygen Therapy of Northern Virginia
Reston, Virginia, United States, 20190
United States, Wisconsin
Fox Valley Wellness Center
Fond du Lac, Wisconsin, United States, 54935
Sponsors and Collaborators
International Hyperbaric Medical Foundation
Investigators
Study Director: B Robert Mozayeni, MD International Hyperbaric Medical Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: 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: May 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by International Hyperbaric Medical Foundation:
traumatic
brain
injury
post-traumatic
stress
hyperbaric
oxygen
HBOT
TBI
PTSD

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Brain Injuries
Post-Concussion Syndrome
Wounds and Injuries
Anxiety Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on July 24, 2014