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Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or Post-Traumatic Stress Disorder | Clinical Trials | Clareo Health

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Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or Post-Traumatic Stress Disorder

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

NCT01105962•International Hyperbaric Medical Foundation

View on ClinicalTrials.gov

Summary

This is an observational research study whose purposes are to see: 1. if 40 Hyperbaric Oxygen Therapy sessions at 1.5 atmospheres (HBOT 1.5) or more (60, or 80 HBOT's) help, worsen, or have no effect on subjects with chronic TBI/PCS (Traumatic Brain Injury/Post-Concussion Syndrome) and/or PTSD (Post-Traumatic Stress Disorder). 2. if improvements or worsening of symptoms can be recorded with computerized and written tests for memory and thinking, and with questionnaires about the subject's quality of life and health. 3. determine the long-term outcome of the treatment. 4. confirm, in large numbers of study participants at multiple sites nationwide, the strong positive results obtained in pilot studies

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Any 18-65 year-old patient with mild-moderate TBI or PTSD. (If a military injury, subject may be active duty or a veteran. If active duty, participants will have to voluntarily contact NBIRR.)
•2. Have demonstrated a \>20% decrement (compared to pre-deployment baseline) in ANAM composite score or specific sub-score with regard to "simple reaction time" and/or "procedural reaction time".
•3. Have a diagnosis of TBI, chronic TBI/PCS or TBI/PCS/PTSD or PTSD made by a military (military etiology of blast injury) or civilian specialist.
•4. Negative pregnancy test in females.
•5. Less than 90% on the Percent Back to Normal Rating Scale. (If patient is considered 100% normal before TBI, patient should be less than 90% normal for entry into the study).

Exclusion Criteria

•1. Pulmonary disease that precludes HBOT (e.g., asthma unresponsive to medication, bullous emphysema).
•2. Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year).
•3. Severe confinement anxiety (claustrophobia; e.g., patients who require anesthesia conscious sedation for MRI or who cannot go in elevators).
•4. Pregnancy.
•5. Other pre-TBI neurological diagnoses.(seizure disorders, multiple sclerosis, Parkinson's, Lyme, etc.)
•6. Participation in another experimental trial with active intervention.
•7. High probability of inability to complete the experimental protocol (e.g. terminal condition).
•8. Past or current history of mental retardation unless diagnosed post TBI (baseline IQ ≤ 70).
•9. Pre- or post-TBI history of systemic illness with impact on central nervous system. (Principal Investigator in consultation with study sponsor Medical Officer will make the ultimate decision).
•10. Any pre-existing chronic infection not related to battlefield injuries or government service.

Locations (10)

San Francisco Institute for Hyperbaric Medicine

San Francisco, California, United States

Rocky Mountain Hyperbaric Institute

Boulder, Colorado, United States

Hyperbaric Services of the Palm Beaches

Delray Beach, Florida, United States

Hyperbaric Medicine Inc. of Florida

Fort Walton Beach, Florida, United States

Idaho Wound Care & Hyperbaric Medicine

Pocatello, Idaho, United States

Lifeforce Therapies

Plymouth, Minnesota, United States

Hyperbaric Institute of Nevada and Clinical Neurology Specialists

Henderson, Nevada, United States

Alliance Community Hospital Wound Care and Hyperbaric Department

Alliance, Ohio, United States

HBOT NOVA - Hyperbaric Oxygen Therapy of Northern Virginia

Reston, Virginia, United States

Fox Valley Wellness Center

Fond du Lac, Wisconsin, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

March 1, 2015

Completion Date

March 1, 2015

Last Updated

September 20, 2016

Enrollment

133

ACTUAL participants

Conditions

Traumatic Brain InjuryPost-traumatic Stress Disorder

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Traumatic Brain Injury

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RECRUITING

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Traumatic Brain Injury

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RECRUITINGNA

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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: September 20, 2016Data 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.

View ClinicalTrials.gov Terms and Conditions

Hyperbaric Oxygen Therapy in Chronic Traumatic Brain Injury or Post-Traumatic Stress Disorder

Inclusion Criteria

Exclusion Criteria

Clinical Randomisation of an Anti-fibrinolytic in Symptomatic Mild Head Injury in Older Adults

A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury

EMDR Integrative Group Protocol and Individual Treatment for Patients With Cancer: A Pilot Study

Hemodynamic ABI Monitor

Multimodal, Enriched Environment for Rehabilitation in Chronic Traumatic Brain Injury

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