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

NCT01105962 | Terminated DMC

• 1 other identifier: NBIRR-01
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 10

Brief Summary

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

1. 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. 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. 3.determine the long-term outcome of the treatment.
4. 4.confirm, in large numbers of study participants at multiple sites nationwide, the strong positive results obtained in pilot studies

Conditions

Traumatic Brain Injury; Post-traumatic Stress Disorder

Keywords

traumatic; brain; injury; post-traumatic; stress; hyperbaric; oxygen; HBOT; TBI; PTSD

Outcome Measures

Primary Outcomes (1)

• Cognitive Function

  2-6mo then every 6 months for 2yrs

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.)
• 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".
• 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.
• Negative pregnancy test in females.
• 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).

You may not qualify if:

• Pulmonary disease that precludes HBOT (e.g., asthma unresponsive to medication, bullous emphysema).
• 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).
• Severe confinement anxiety (claustrophobia; e.g., patients who require anesthesia conscious sedation for MRI or who cannot go in elevators).
• Pregnancy.
• Other pre-TBI neurological diagnoses.(seizure disorders, multiple sclerosis, Parkinson's, Lyme, etc.)
• Participation in another experimental trial with active intervention.
• High probability of inability to complete the experimental protocol (e.g. terminal condition).
• Past or current history of mental retardation unless diagnosed post TBI (baseline IQ ≤ 70).
• 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).
• Any pre-existing chronic infection not related to battlefield injuries or government service.

Sponsors & Collaborators

• International Hyperbaric Medical Foundation: lead

Study Sites (10)

San Francisco Institute for Hyperbaric Medicine

San Francisco, California, 94107, United States

Location

Rocky Mountain Hyperbaric Institute

Boulder, Colorado, 80301, United States

Location

Hyperbaric Services of the Palm Beaches

Delray Beach, Florida, 33484, United States

Location

Hyperbaric Medicine Inc. of Florida

Fort Walton Beach, Florida, 32547, United States

Location

Idaho Wound Care & Hyperbaric Medicine

Pocatello, Idaho, 83201, United States

Location

Lifeforce Therapies

Plymouth, Minnesota, 55447, United States

Location

Hyperbaric Institute of Nevada and Clinical Neurology Specialists

Henderson, Nevada, 89012, United States

Location

Alliance Community Hospital Wound Care and Hyperbaric Department

Alliance, Ohio, 44601, United States

Location

HBOT NOVA - Hyperbaric Oxygen Therapy of Northern Virginia

Reston, Virginia, 20190, United States

Location

Fox Valley Wellness Center

Fond du Lac, Wisconsin, 54935, United States

Location

Related Links

• National Brain Injury Rescue and Rehabilitation Project

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stress Disorders, Post-Traumatic; Wounds and Injuries

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• B Robert Mozayeni, MD

  International Hyperbaric Medical Foundation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2010
• First Posted: April 19, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

US (10)