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

Post Traumatic Stress Disorder Clinical Trial

Official title:

HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760734
• Other study ID #: LSU IRB #7051
• Status: Completed
• Phase: Phase 1
• First received: September 25, 2008
• Last updated: April 16, 2017
• Start date: September 2008
• Est. completion date: June 2011

Study information

• Verified date: April 2017
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Brain Injuries
• Chronic Post Traumatic Stress Disorder
• Disease
• Post Concussion Syndrome
• Post Traumatic Stress Disorder
• Post-Concussion Syndrome
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Syndrome
• TBI (Traumatic Brain Injury)
• Wounds and Injuries

Intervention

Drug:
• Low pressure hyperbaric oxygen therapy
HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments
• Low pressure hyperbaric oxygen therapy
HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments

Locations

Country	Name	City	State
United States	LSU Health Sciences Center	New Orleans	Louisiana

Sponsors (5)

Lead Sponsor	Collaborator
Paul G. Harch, M.D.	Coalition to Support America's Heroes, Marine Corps Law Enforcement Foundation, Semper Fi Fund, Thirty-eight other contributors

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Neur — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychometric testing		30 days
Secondary	SPECT brain imaging		30 days
Secondary	Quality of life measurements		30 days
Secondary	Return to school or work		6 months

External Links

•   epub ahead of print