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

Phase 1

Completed

• Conditions: TBI (Traumatic Brain Injury); Post Traumatic Stress Disorder; Post Concussion Syndrome; Chronic Post Traumatic Stress Disorder
• Interventions: Drug: Low pressure hyperbaric oxygen therapy

• Registration Number: NCT00760734
• Lead Sponsor: Paul G. Harch, M.D.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-26
• Primary Completion: 2010-09
• Study Completion: 2011-06
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-16
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hyperbaric oxygen therapy-TBI/PCS	Low pressure hyperbaric oxygen therapy	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
Hyperbaric Oxygen Therapy-PCS/PTSD	Low pressure hyperbaric oxygen therapy	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

Primary Outcome Measures

Name	Time	Method
Psychometric testing	30 days

Secondary Outcome Measures

Name	Time	Method
Return to school or work	6 months
SPECT brain imaging	30 days
Quality of life measurements	30 days

Trial Locations

Locations (1)

LSU Health Sciences Center; 🇺🇸 New Orleans, Louisiana, United States