Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
George Wolf, San Antonio Military Medical Center
ClinicalTrials.gov Identifier:
NCT00810615
First received: December 17, 2008
Last updated: February 28, 2013
Last verified: February 2013
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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:


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

Primary Outcome Measures:
  • Computer cognitive test scores [ Time Frame: six weeks post hyperbaric exposure series ] [ Designated as safety issue: No ]
  • Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) scores [ Time Frame: six weeks post hyperbaric exposure series ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional MRI [ Time Frame: six weeks post hyperbaric exposure series ] [ Designated as safety issue: No ]
  • Biomarkers [ Time Frame: six weeks post hyperbaric exposure series ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: February 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Sham treatment
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.
Other Names:
  • hyperbaric oxygen
  • HBOT
  • HBO
Experimental: 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.
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.
Other Names:
  • hyperbaric oxygen
  • HBOT
  • HBO

  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 since 7 October 2001
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
San Antonio Military Medical Center
Investigators
Study Director: E. George Wolf, M.D. SAMMC Hyperbaric Center
Principal Investigator: Leonardo C Profenna, M.D. SAMMC Hyperbaric Center
  More Information

No publications provided

Responsible Party: George Wolf, Study Director, San Antonio Military Medical Center
ClinicalTrials.gov Identifier: NCT00810615     History of Changes
Other Study ID Numbers: FWH20080137H
Study First Received: December 17, 2008
Last Updated: February 28, 2013
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

Additional relevant MeSH terms:
Brain Injuries
Brain Injury, Chronic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Damage, Chronic

ClinicalTrials.gov processed this record on August 21, 2014