Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or Post-Traumatic Stress Disorder
Status: | Recruiting |
---|---|
Conditions: | Hospital, Neurology, Psychiatric |
Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 5/5/2014 |
Start Date: | May 2010 |
End Date: | April 2018 |
Contact: | B Robert Mozayeni, MD |
Email: | callcenter@nbirr.org |
Phone: | 800-288-9328 |
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
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
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.
We found this trial at
10
sites
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