Deep Brain Stimulation for the Treatment of Obesity

Ali Rezai, MD3 enrolled

Overview

The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS) as a treatment option for obesity.

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

Deep Brain Stimulation DeviceDEVICE

Deep brain stimulation surgery

Eligibility

Sex: ALLMin age: 22 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University Medical Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Percentage of excess weight loss

The primary outcome measure at the conclusion of the study will be percent of excess weight loss (EWL).

Time frame: 2 years

Data from ClinicalTrials.gov

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