Phase 2 N=50 Randomized Single-blind Treatment

Treatment of Traumatic Brain Injury With Hyperbaric Oxygen Therapy

Brain Injury, Chronic

Bottom Line

View on ClinicalTrials.gov: NCT00810615 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2018

Primary outcome: Primary: Computer Cognitive Test Scores - ImPACT Verbal Memory — 70.48; 74.21; 78.12; 75.36 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Hyperbaric oxygen @ 2.4 ATA (Other); Sham treatment (Other)
Age: Adult · 19+ yrs
Sex: All
Sponsor: San Antonio Military Medical Center
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Computer Cognitive Test Scores - ImPACT Verbal Memory	70.48; 74.21; 78.12; 75.36	—
PRIMARY Posttraumatic Stress Disorder Checklist - Military Version (PCL-M) Scores	48.88; 50.38; -10.125; -8.875; -8.292; -8.625	0.05
PRIMARY Computer Cognitive Test Scores - ImPACT Visual Memory	56.56; 59.8; 64.72; 66.8	—
PRIMARY Computer Cognitive Test Scores - ImPACT Processing Speed	30.26; 29.62; 36.71; 33.84	—
PRIMARY Computer Cognitive Test Scores - ImPACT Reaction Time	0.739; 0.725; 0.677; 0.712	—
PRIMARY Computer Cognitive Test Scores - BrainCheckers Simple Reaction Time	142.21; 135.79; 174.96; 171.83	—
PRIMARY Computer Cognitive Test Scores - BrainCheckers Code Substitution	39.20; 37.42; 43.39; 40.71	—
PRIMARY Computer Cognitive Test Scores - BrainCheckers Procedural Reaction Time	81.63; 81.17; 85.78; 86.78	—
PRIMARY Computer Cognitive Test Scores - BrainCheckers Go-NoGo Reaction Time	119.67; 116.52; 131.70; 129.17	—
PRIMARY Computer Cognitive Test Scores - BrainCheckers Matching To Sample	20.00; 23.71; 28.22; 24.42	—
PRIMARY Computer Cognitive Test Scores - BrainCheckers Code Sub Recall	29.88; 36.38; 47.57; 44.08	—
SECONDARY Functional MRI	—	—
SECONDARY Stem Cells: CD_34	—	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00810615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.