Clinical trial NCT01105962: Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or Post-Traumatic Stress Disorder
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Traumatic Brain Injury
Post-traumatic Stress Disorder
Keywords: traumatic
brain
injury
post-traumatic
stress
hyperbaric
oxygen
HBOT
TBI
PTSD
Lead sponsor: International Hyperbaric Medical Foundation
Sponsor class: OTHER
First posted: 2010-04-19
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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


Eligibility 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.

Primary outcomes:
measure: Cognitive Function
timeFrame: 2-6mo then every 6 months for 2yrs
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Institute for Hyperbaric Medicine
state: California
city: Boulder
country: United States
facility: Rocky Mountain Hyperbaric Institute
state: Colorado
city: Del Ray Beach
country: United States
facility: Hyperbaric Services of the Palm Beaches
state: Florida
city: Ft. Walton Beach
country: United States
facility: Hyperbaric Medicine Inc. of Florida
state: Florida
city: Pocatello
country: United States
facility: Idaho Wound Care & Hyperbaric Medicine
state: Idaho
city: Plymouth
country: United States
facility: Lifeforce Therapies
state: Minnesota
city: Henderson
country: United States
facility: Hyperbaric Institute of Nevada and Clinical Neurology Specialists
state: Nevada
city: Alliance
country: United States
facility: Alliance Community Hospital Wound Care and Hyperbaric Department
state: Ohio
city: Reston
country: United States
facility: HBOT NOVA - Hyperbaric Oxygen Therapy of Northern Virginia
state: Virginia
city: Fond du Lac
country: United States
facility: Fox Valley Wellness Center
state: Wisconsin
Study officials:
affiliation: International Hyperbaric Medical Foundation
name: B Robert Mozayeni, MD
role: STUDY_DIRECTOR
References: