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

Traumatic Brain Injury Clinical Trial

— NBIRR-1  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01105962
• Other study ID #: NBIRR-01
• Status: Terminated
• Phase: N/A
• First received: April 15, 2010
• Last updated: September 17, 2016
• Start date: May 2010
• Est. completion date: March 2015

Study information

• Verified date: September 2016
• Source: International Hyperbaric Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 133
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Disease
• Post-Concussion Syndrome
• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Alliance Community Hospital Wound Care and Hyperbaric Department	Alliance	Ohio
United States	Rocky Mountain Hyperbaric Institute	Boulder	Colorado
United States	Hyperbaric Services of the Palm Beaches	Del Ray Beach	Florida
United States	Fox Valley Wellness Center	Fond du Lac	Wisconsin
United States	Hyperbaric Medicine Inc. of Florida	Ft. Walton Beach	Florida
United States	Hyperbaric Institute of Nevada and Clinical Neurology Specialists	Henderson	Nevada
United States	Lifeforce Therapies	Plymouth	Minnesota
United States	Idaho Wound Care & Hyperbaric Medicine	Pocatello	Idaho
United States	HBOT NOVA - Hyperbaric Oxygen Therapy of Northern Virginia	Reston	Virginia
United States	San Francisco Institute for Hyperbaric Medicine	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
International Hyperbaric Medical Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Function		2-6mo then every 6 months for 2yrs	No

External Links

•   National Brain Injury Rescue and Rehabilitation Project