Clinical trial NCT00760734: Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)
Official title: HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: TBI (Traumatic Brain Injury)
Post Concussion Syndrome
Post Traumatic Stress Disorder
Chronic Post Traumatic Stress Disorder
Keywords: Chronic traumatic brain injury
Post concussion syndrome
Post traumatic stress disorder
Chronic post traumatic stress disorder
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: Semper Fi Fund
name: Marine Corps-Law Enforcement Foundation
name: Coalition to Support America's Heroes
name: Thirty-eight other contributors
First posted: 2008-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Adults, 18-65 years old
* One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001
* 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 Michigan Alcohol Screening Test (MAST)
* Negative Drug Abuse Screening Test (DAST)
* 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)

Primary outcomes:
measure: Psychometric testing
timeFrame: 30 days
Secondary outcomes:
measure: SPECT brain imaging
timeFrame: 30 days
measure: Quality of life measurements
timeFrame: 30 days
measure: Return to school or work
timeFrame: 6 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: LSU Health Sciences Center
state: Louisiana
Study officials:
affiliation: Louisiana State University Health Sciences Center in New Orleans
name: Paul G Harch, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Harch PG, Andrews SR, Fogarty EF, Amen D, Pezzullo JC, Lucarini J, Aubrey C, Taylor DV, Staab PK, Van Meter KW. A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder. J Neurotrauma. 2012 Jan 1;29(1):168-85. doi: 10.1089/neu.2011.1895. Epub 2011 Nov 22.