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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-06-30

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hyperbaric oxygen therapy-TBI/PCS

Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT

Group Type EXPERIMENTAL

Low pressure hyperbaric oxygen therapy

Intervention Type DRUG

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

Low pressure hyperbaric oxygen therapy

Intervention Type DRUG

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

Hyperbaric Oxygen Therapy-PCS/PTSD

Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT

Group Type EXPERIMENTAL

Low pressure hyperbaric oxygen therapy

Intervention Type DRUG

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

Low pressure hyperbaric oxygen therapy

Intervention Type DRUG

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

Interventions

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Low pressure hyperbaric oxygen therapy

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

Intervention Type DRUG

Low pressure hyperbaric oxygen therapy

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

Intervention Type DRUG

Other Intervention Names

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HBOT HBOT

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No