Deep Brain Stimulation For Morbid, Treatment-Refractory, Obesity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Percentage of excess weight loss
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
DBS Surgery
All patients enrolled will undergo DBS implantation in the targeted region to assess the safety of the procedure and the efficacy through weight loss.
Intervention: Deep Brain Stimulation Device (Device)
Outcomes
Primary Outcomes
Percentage of excess weight loss
Time Frame: 2 years
The primary outcome measure at the conclusion of the study will be percent of excess weight loss (EWL).
Secondary Outcomes
No secondary outcomes reported
Investigators
Ali Rezai, MD
Professor of Neurological Surgery
Ohio State University