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

Study Overview
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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.

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

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

Intervention / Treatment
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* Drug: Low pressure hyperbaric oxygen therapy
* Drug: Low pressure hyperbaric oxygen therapy


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperbaric oxygen therapy-TBI/PCS<br>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 | Drug: Low pressure hyperbaric oxygen therapy<br>* HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments<br>* Other names: HBOT;Drug: Low pressure hyperbaric oxygen therapy<br>* HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments<br>* Other names: HBOT;|
| Experimental: Hyperbaric Oxygen Therapy-PCS/PTSD<br>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 | Drug: Low pressure hyperbaric oxygen therapy<br>* HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments<br>* Other names: HBOT;Drug: Low pressure hyperbaric oxygen therapy<br>* HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments<br>* Other names: HBOT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychometric testing |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SPECT brain imaging |  | 30 days | 
| Quality of life measurements |  | 30 days | 
| Return to school or work |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic traumatic brain injury, Post concussion syndrome, Post traumatic stress disorder, Chronic post traumatic stress disorder