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Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy

NCT00810615 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-08-13

Study results available
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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.

Conditions

  • Brain Injury, Chronic

Interventions

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

Sham treatment

Sponsors & Collaborators

  • San Antonio Military Medical Center

    lead FED

Principal Investigators

  • E. George Wolf, M.D. · SAMMC Hyperbaric Medicine

  • Leonardo C Profenna, M.D. · SAMMC Hyperbaric Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-01-31
Completion
2011-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00810615 on ClinicalTrials.gov