Pilot Study of Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)



Status:Completed
Conditions:Hospital, Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - 45
Updated:5/3/2014
Start Date:September 2008
End Date:May 2009

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Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD) Pilot Trial

This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric
oxygen therapy can improve cognition and brain imaging in subjects with either chronic
mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or
chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.


Inclusion Criteria:

- Adults, 18-45 years old

- One or more mild-moderate TBI's characterized by loss of consciousness due to blast
injury that is a minimum of one and maximum of four years old

- Absence of acute cardiac arrest or hemorrhagic shock at time of TBI.

- Absence of intracranial neurosurgery post-TBI

- Disability Rating Scale of 0-3

- Negative Addiction Severity Index (Severity score of less than 2)

- Negative urine toxicology screen for drugs of abuse

- Negative pregnancy test in females

- Otherwise good health

- Less than 90% on the Percent Back to Normal Rating Scale

Exclusion Criteria:

- Pulmonary disease that precludes HBOT

- Unstable medical conditions that are contraindicated in HBOT

- Severe confinement anxiety

- Pregnancy

- Other pre-TBI neurological diagnoses

- Pre or post TBI history of substance abuse

- Pre or post TBI history of alcoholism.

- Participation in another experimental trial with active intervention.

- High probability of inability to complete the experimental protocol.

- Previous HBOT

- History of hospitalization for past TBI, stroke, nonfebrile seizures, or any seizure
history other than seizure at the time of TBI

- Past or current history of mental retardation (baseline FSIQ < 71.

- Pre/post-TBI history of systemic illness with impact on CNS (P.I.'s decision)
We found this trial at
1
site
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
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