Deep Brain Stimulation for the Treatment of Obesity

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: Deep Brain Stimulation Device

• 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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-13
• Study First Posted: 2012-01-19
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

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

Arm && Interventions

Group	Intervention	Description
DBS Surgery	Deep Brain Stimulation Device	All patients enrolled will undergo DBS implantation in the targeted region to assess the safety of the procedure and the efficacy through weight loss.

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).

Trial Locations

Locations (1)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States