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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2008 by Louisiana State University Health Sciences Center in New Orleans. Recruitment status was Recruiting

First Received on September 25, 2008. No Changes Posted

Sponsor:	Louisiana State University Health Sciences Center in New Orleans
Information provided by:	Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier:	NCT00760734

Purpose

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.

Condition	Intervention	Phase
TBI (Traumatic Brain Injury) Post Concussion Syndrome Post Traumatic Stress Disorder Chronic Post Traumatic Stress Disorder	Drug: Low pressure hyperbaric oxygen therapy	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD) Pilot Trial

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy Post-Traumatic Stress Disorder Traumatic Brain Injury

U.S. FDA Resources

Further study details as provided by Louisiana State University Health Sciences Center in New Orleans:

Primary Outcome Measures:

Psychometric testing [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SPECT brain imaging [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Quality of life measurements [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Return to school or work [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	September 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1-TBI (PCS) Subjects with post-concussion syndrome at least one year after blast-induced mild-moderate traumatic brain injury will receive HBOT at 1.5 ATA/60 minutes twice/day, 5d/week for 40 or 80 treatments	Drug: Low pressure hyperbaric oxygen therapy HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments Other Name: HBOT Drug: Low pressure hyperbaric oxygen therapy HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments Other Name: HBOT
Experimental: 2-TBI/PTSD Subjects with post-concussion syndrome and PTSD at least one year after blast-induced mild-moderate traumatic brain injury will receive HBOT at 1.5 ATA/60 minutes twice/day, 5d/week for 40 or 80 treatments	Drug: Low pressure hyperbaric oxygen therapy HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments Other Name: HBOT Drug: Low pressure hyperbaric oxygen therapy HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments Other Name: HBOT

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760734

Locations

United States, Louisiana
LSU Health Sciences Center	Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Paul G Harch, M.D. paulharchmd@aol.com
Contact: Juliette Lucarini, R.N> juliettelucarini@gmail.com
Principal Investigator: Paul G Harch, M.D.

Sponsors and Collaborators

Louisiana State University Health Sciences Center in New Orleans

Investigators

Principal Investigator:

Paul G Harch, M.D.

Louisiana State University Health Sciences Center in New Orleans

More Information

No publications provided

Responsible Party:	Paul G. Harch, M.D./Principal Investigator, Louisiana State University
ClinicalTrials.gov Identifier:	NCT00760734 History of Changes
Other Study ID Numbers:	LSU IRB #7051
Study First Received:	September 25, 2008
Last Updated:	September 25, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Louisiana State University Health Sciences Center in New Orleans:

Chronic traumatic brain injury
Post concussion syndrome
Post traumatic stress disorder
Chronic post traumatic stress disorder

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Brain Injuries
Post-Concussion Syndrome
Anxiety Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on February 09, 2012