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Hyperbaric Oxygen Therapy (HBOT) for Traumatic Brain Injury
Phase 3
Waitlist Available
Led By Paul G Harch, MD
Research Sponsored by Louisiana State University Health Sciences Center in New Orleans
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
Objective/Hypothesis: An eight-week course of forty low-pressure Hyperbaric Oxygen Treatment's (HBOT's) can significantly improve symptoms and cognitive function in subjects with the persistent-post concussion syndrome (PPCS) of mild traumatic brain injury (mTBI).
Eligible Conditions
- Traumatic Brain Injury
- Post-Concussion Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Group I: No Hyperbaric Oxygen Treatment (HBOT)Experimental Treatment2 Interventions
Subjects will receive eight weeks of no hyperbaric treatment while they continue any pre-study maintenance medication and/or pre-study counseling. Subjects will be retested and the control group will be crossed over to receive the identical 40 HBOTs of the HBOT group.
Group II: Hyperbaric Oxygen Therapy (HBOT)Experimental Treatment1 Intervention
Hyperbaric Oxygen Therapy at 1.5 ATA (atmospheres absolute). The subjects will receive 40 low pressure HBOT's on a once/day, 5d/week eight week schedule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hyperbaric Oxygen
2005
Completed Phase 3
~260
Find a Location
Who is running the clinical trial?
U.S. Army Medical Research and Development CommandFED
289 Previous Clinical Trials
246,012 Total Patients Enrolled
Louisiana State University Health Sciences Center in New OrleansLead Sponsor
119 Previous Clinical Trials
44,769 Total Patients Enrolled
Paul G Harch, MDPrincipal InvestigatorLouisiana State University Health Sciences Center in New Orleans
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