Deep Brain Stimulation For Morbid, Treatment-Refractory, Obesity

Ali Rezai, MD1 site in 1 country3 target enrollmentJanuary 2012

ConditionsObesity

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Obesity
Sponsor: Ali Rezai, MD
Enrollment: 3
Locations: 1
Primary Endpoint: Percentage of excess weight loss
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

November 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ali Rezai, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Ali Rezai, MD

Professor of Neurological Surgery

Ohio State University

Eligibility Criteria

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