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Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy

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ClinicalTrials.gov Identifier: NCT00810615
Recruitment Status : Completed
First Posted : December 18, 2008
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
George Wolf, San Antonio Military Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Brain Injury, Chronic Other: Hyperbaric oxygen @ 2.4 ATA Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Treatment of Moderate to Mild Cognitive Dysfunction Caused by Traumatic Brain Injury (TBI) With Hyperbaric Oxygen Therapy (HBOT)
Study Start Date : February 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Computer cognitive test scores [ Time Frame: six weeks post hyperbaric exposure series ]
  2. Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) scores [ Time Frame: six weeks post hyperbaric exposure series ]

Secondary Outcome Measures :
  1. Functional MRI [ Time Frame: six weeks post hyperbaric exposure series ]
  2. Biomarkers [ Time Frame: six weeks post hyperbaric exposure series ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: George Wolf, Study Director, San Antonio Military Medical Center
ClinicalTrials.gov Identifier: NCT00810615     History of Changes
Other Study ID Numbers: FWH20080137H
First Posted: December 18, 2008    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: February 2013

Keywords provided by George Wolf, San Antonio Military Medical Center:
chronic TBI
cognitive function
PTSD
HBO
hyperbaric
oxygen
chronic brain injury

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