Obesity
Conditions
Keywords
Obesity, DBS
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.
Interventions
DEVICEDeep Brain Stimulation Device
Deep brain stimulation surgery
Sponsors
Ali Rezai, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed