Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy - Full Text View

Sponsored by:	San Antonio Military Medical Center
Information provided by:	San Antonio Military Medical Center
ClinicalTrials.gov Identifier:	NCT00810615

Purpose

The purpose of this study is to determine if hyperbaric oxygen therapy (HBOT) improves the cognitive function of OIF/OEF individuals who have chronic mild to moderate traumatic brain injury (TBI). Cognitive function includes such things as thinking, remembering, recognition, concentration ability and perception. Traumatic brain injury is common with head injuries caused by blows to the head, nearby explosions, or concussion. Subjects will be assigned to an intervention or sham arm. Computer based cognitive tests will be used as outcome measures.

Subjects are enrolled by invitation only.

Condition	Intervention	Phase
Brain Injury, Chronic	Other: Hyperbaric oxygen @ 2.4 ATA	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
Official Title:	Treatment of Moderate to Mild Cognitive Dysfunction Caused by Traumatic Brain Injury (TBI) With Hyperbaric Oxygen Therapy (HBOT)

Resource links provided by NLM:

MedlinePlus related topics: Traumatic Brain Injury

U.S. FDA Resources

Further study details as provided by San Antonio Military Medical Center:

Primary Outcome Measures:

Computer cognitive test scores [ Time Frame: Pre exposure, every 5 HBOT, six weeks post HBOT ] [ Designated as safety issue: No ]
Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) scores [ Time Frame: pre exposure, every 5 HBOT, six weeks post HBOT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Functional MRI [ Time Frame: pre exposure and six weeks post exposure ] [ Designated as safety issue: No ]
Biomarkers [ Time Frame: pre exposure, after 15 HBOT, six weeks post HBOT ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sham treatment: Sham Comparator Subject will breath air at less than 1.3 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at less that 1.3 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.	Other: Hyperbaric oxygen @ 2.4 ATA Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.
Hyperbaric oxygen 2.4 ATA: Experimental Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.	Other: Hyperbaric oxygen @ 2.4 ATA Subject will breath 100% oxygen at 2.4 Atmospheres Absolute (ATA) in three 30 minute periods separated by 10 minutes of breathing air at 2.4 ATA. Hyperbaric exposures will be done up to 5 times per week with a total number of 30 exposures.

Eligibility

Ages Eligible for Study:	19 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

neurology diagnosis of mild to moderate TBI
injury sustained during OIF/OEF military activities
perception of cognitive dysfunction following their injury
stable mental status for at least two months
stable psychotropic medication history for at least one month
ability to perform computer based cognitive testing (must be capable using a mouse and PDA pointer and readily view the displays)
TBI occurrence not more than 4 years prior
ability to consent

Exclusion Criteria:

medical conditions that prevent subject from participating in hyperbaric environments
previous hyperbaric oxygen treatments since being diagnosed with TBI
history of alcohol abuse
history of drug abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810615

Sponsors and Collaborators

San Antonio Military Medical Center

Investigators

Study Chair:	Robert S. Michaelson, D.O.	SAMMC Hyperbaric Center
Study Director:	E. George Wolf, M.D.	SAMMC Hyperbaric Center
Principal Investigator:	Jason J. Cho, M.D.	SAMMC Hyperbaric Center

More Information

No publications provided

Responsible Party:	SAMMC Hyperbaric Center ( Col Robert Michaelson )
Study ID Numbers:	FWH20080137H
Study First Received:	December 17, 2008
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00810615 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by San Antonio Military Medical Center:

chronic TBI
cognitive function
PTSD
HBO

hyperbaric
oxygen
chronic brain injury

Study placed in the following topic categories:

Craniocerebral Trauma
Brain Damage, Chronic
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Trauma, Nervous System
Brain Diseases
Brain Injuries
Brain Injury, Chronic

Additional relevant MeSH terms:

Craniocerebral Trauma
Brain Damage, Chronic
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin

Central Nervous System Diseases
Trauma, Nervous System
Brain Diseases
Brain Injuries
Brain Injury, Chronic

ClinicalTrials.gov processed this record on September 03, 2009