Deep Brain Stimulation for the Treatment of Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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DBS Surgery

All patients enrolled will undergo DBS implantation in the targeted region to assess the safety of the procedure and the efficacy through weight loss.

Group Type EXPERIMENTAL

Deep Brain Stimulation Device

Intervention Type DEVICE

Deep brain stimulation surgery

Interventions

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Deep Brain Stimulation Device

Deep brain stimulation surgery

Intervention Type DEVICE

Other Intervention Names

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Reclaim

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No