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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) | Clinical Trials | Clareo Health

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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)

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

NCT00760734•Paul G. Harch, M.D.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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
+3 more criteria

Locations (1)

LSU Health Sciences Center

New Orleans, Louisiana, United States

Key Dates

Start Date

September 1, 2008

Primary Completion Date

September 1, 2010

Completion Date

June 1, 2011

Last Updated

April 18, 2017

Enrollment

ACTUAL participants

Conditions

TBI (Traumatic Brain Injury)Post Concussion SyndromePost Traumatic Stress DisorderChronic Post Traumatic Stress Disorder

Interventions

Low pressure hyperbaric oxygen therapy

DRUG

Low pressure hyperbaric oxygen therapy

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

Stepped Care for Posttraumatic Stress Disorder Study

Digital Biofeedback for Combat Veterans Diagnosed With PTSD

Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury

A Pilot Study of Trauma-Focused Cognitive-Behavioral Therapy for Treatment of Post-traumatic Stress in Adults.

Advanced Wireless Augmented Reality-Enhanced Exposure Therapy for Posttraumatic Stress Disorder

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