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

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

Study Overview

• Status: Terminated
• Conditions: Traumatic Brain Injury; Post-traumatic Stress Disorder

• Study Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • San Francisco Institute for Hyperbaric Medicine
  • Colorado
    • Boulder, Colorado, United States, 80301
      • Rocky Mountain Hyperbaric Institute
  • Florida
    • Del Ray Beach, Florida, United States, 33484
      • Hyperbaric Services of the Palm Beaches
    • Ft. Walton Beach, Florida, United States, 32547
      • Hyperbaric Medicine Inc. of Florida
  • Idaho
    • Pocatello, Idaho, United States, 83201
      • Idaho Wound Care & Hyperbaric Medicine
  • Minnesota
    • Plymouth, Minnesota, United States, 55447
      • Lifeforce Therapies
  • Nevada
    • Henderson, Nevada, United States, 89012
      • Hyperbaric Institute of Nevada and Clinical Neurology Specialists
  • Ohio
    • Alliance, Ohio, United States, 44601
      • Alliance Community Hospital Wound Care and Hyperbaric Department
  • Virginia
    • Reston, Virginia, United States, 20190
      • HBOT NOVA - Hyperbaric Oxygen Therapy of Northern Virginia
  • Wisconsin
    • Fond du Lac, Wisconsin, United States, 54935
      • Fox Valley Wellness Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cognitive Function	2-6mo then every 6 months for 2yrs

Collaborators and Investigators

• Sponsor: International Hyperbaric Medical Foundation
• Investigators: Study Director: B Robert Mozayeni, MD, International Hyperbaric Medical Foundation

Publications and helpful links

Helpful Links

• National Brain Injury Rescue and Rehabilitation Project

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: April 15, 2010
• First Submitted That Met QC Criteria: April 15, 2010
• First Posted (Estimate): April 19, 2010

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 17, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: PTSD; stress; TBI; injury; brain; oxygen; hyperbaric; traumatic; HBOT; post-traumatic
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Trauma and Stressor Related Disorders; Brain Injuries; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: NBIRR-01