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Completed

NCT Number: NCT00760734

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults, 18-65 years old
  • One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001
  • Absence of acute cardiac arrest or hemorrhagic shock at time of TBI.
  • Absence of intracranial neurosurgery post-TBI
  • Disability Rating Scale of 0-3
  • Negative Michigan Alcohol Screening Test (MAST)
  • Negative Drug Abuse Screening Test (DAST)
  • Negative urine toxicology screen for drugs of abuse
  • Negative pregnancy test in females
  • Otherwise good health
  • Less than 90% on the Percent Back to Normal Rating Scale

Exclusion criteria

  • Pulmonary disease that precludes HBOT
  • Unstable medical conditions that are contraindicated in HBOT
  • Severe confinement anxiety
  • Pregnancy
  • Other pre-TBI neurological diagnoses
  • Pre or post TBI history of substance abuse
  • Pre or post TBI history of alcoholism.
  • Participation in another experimental trial with active intervention.
  • High probability of inability to complete the experimental protocol.
  • Previous HBOT
  • History of hospitalization for past TBI, stroke, nonfebrile seizures, or any seizure history other than seizure at the time of TBI
  • Past or current history of mental retardation (baseline FSIQ < 71.
  • Pre/post-TBI history of systemic illness with impact on CNS (P.I.'s decision)

Treatment and study plan

Low pressure hyperbaric oxygen therapy

Drug

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

Other names: HBOT

Primary outcomes

  1. Psychometric testing

    Time frame: 30 days

Secondary outcomes

  1. SPECT brain imaging

    Time frame: 30 days

  2. Quality of life measurements

    Time frame: 30 days

  3. Return to school or work

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Paul G. Harch, M.D.

Other

Collaborators

  • Coalition to Support America's Heroes
  • Marine Corps-Law Enforcement Foundation
  • Semper Fi Fund
  • Thirty-eight other contributors

Registry information

Official study title

HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Sep 26, 2008
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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