Status:
COMPLETED
Deep Brain Stimulation for the Treatment of Obesity
Lead Sponsor:
Ali Rezai, MD
Conditions:
Obesity
Eligibility:
All Genders
22-60 years
Phase:
NA
Brief Summary
The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS) as a treatment option for obesity.
Detailed Description
The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS) as a treatment option in the management of severe, treatment refractory, morbid obesity.
Eligibility Criteria
Inclusion
- At least 24 months post Roux-en-Y gastric bypass surgery without evidence of a sustained improvement in BMI after gastric bypass surgery for at least 6 months.
- Participant is willing to comply with all follow-up evaluations at the specified times
- Participant is able to provide informed consent
- Fluent in English
Exclusion
- Medical contraindications for general anesthesia, craniotomy, or DBS surgery
- Evidence of neurological disorders, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
- Severe cardiovascular, pulmonary, renal, liver, hematological disease, severe coagulopathy, acute infectious process
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01512134
Start Date
January 1 2012
End Date
November 1 2016
Last Update
March 30 2017
Active Locations (1)
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1
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210