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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
Negative pregnancy test in females. Female subjects will need to have a negative urinalysis result in order to start or continue treatment.
Adults, 18-65 years old.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one week after final hbot
Awards & highlights
Study 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
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one week after final hbot
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one week after final hbot
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neurobehavioral Symptom Inventory (NSI)
Working Memory
Secondary outcome measures
Automated Neuropsychological Assessment Metrics-4 (ANAM-4)
Benton Visual Retention Test with Alternate Forms (Benton VRT)
Category Fluency Test (Animal)
+7 moreTrial 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
285 Previous Clinical Trials
245,100 Total Patients Enrolled
Louisiana State University Health Sciences Center in New OrleansLead Sponsor
113 Previous Clinical Trials
44,132 Total Patients Enrolled
Paul G Harch, MDPrincipal InvestigatorLouisiana State University Health Sciences Center in New Orleans
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Tennessee
What site did they apply to?
Louisiana State University Health Sciences Center-New Orleans
What portion of applicants met pre-screening criteria?
Met criteria
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