Deep Brain Stimulation for the Treatment of Obesity

Ali Rezai, MD

Status: Completed

Conditions: Obesity

Treatments: Device: Deep Brain Stimulation Device

Study type: Interventional

Funder types: Other

Identifiers

NCT01512134

2011H0329

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 22 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

DBS Surgery

Experimental group

Description:

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

Treatment:

Device: Deep Brain Stimulation Device