Deep Brain Stimulation for the Treatment of Obesity
Not Applicable
Completed
- Conditions
- Obesity
- Registration Number
- NCT01512134
- Lead Sponsor
- Ali Rezai, MD
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Percentage of excess weight loss 2 years The primary outcome measure at the conclusion of the study will be percent of excess weight loss (EWL).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
The Ohio State University Medical Center🇺🇸Columbus, Ohio, United States