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Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)

NCT00760734 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-04-18

No results posted yet for this study

Summary

This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.

Conditions

  • TBI (Traumatic Brain Injury)
  • Post Concussion Syndrome
  • Post Traumatic Stress Disorder
  • Chronic Post Traumatic Stress Disorder

Interventions

DRUG

Low pressure hyperbaric oxygen therapy

HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments

DRUG

Low pressure hyperbaric oxygen therapy

HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments

Sponsors & Collaborators

  • Semper Fi Fund

    collaborator UNKNOWN

  • Marine Corps-Law Enforcement Foundation

    collaborator OTHER

  • Coalition to Support America's Heroes

    collaborator UNKNOWN

  • Thirty-eight other contributors

    collaborator UNKNOWN

  • Paul G. Harch, M.D.

    lead OTHER

Principal Investigators

  • Paul G Harch, M.D. · Louisiana State University Health Sciences Center in New Orleans

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-09-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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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 NCT00760734 on ClinicalTrials.gov