Deep Brain Stimulation for the Treatment of Obesity

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

Completed

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep Brain Stimulation Device

Device

Deep brain stimulation surgery

Other names: Reclaim

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).

Sponsors and collaborators

Lead sponsor

Ali Rezai, MD

Other

Registry information

Official study title

Deep Brain Stimulation For Morbid, Treatment-Refractory, Obesity

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Jan 19, 2012
Registry last updated: Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed