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Deep Brain Stimulation for the Treatment of Obesity

This study has been completed.
Information provided by (Responsible Party):
Ali Rezai, MD, The Ohio State University Identifier:
First received: January 11, 2012
Last updated: March 28, 2017
Last verified: March 2017
The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS) as a treatment option for obesity.

Condition Intervention
Device: Deep Brain Stimulation Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Device Feasibility
Official Title: Deep Brain Stimulation For Morbid, Treatment-Refractory, Obesity

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • 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).

Enrollment: 3
Study Start Date: January 2012
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: Deep Brain Stimulation Device
Deep brain stimulation surgery
Other Name: Reclaim

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.

Ages Eligible for Study:   22 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01512134

United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ali Rezai, MD
Principal Investigator: Ali Rezai, MD Ohio State University
  More Information

Responsible Party: Ali Rezai, MD, Professor of Neurological Surgery, The Ohio State University Identifier: NCT01512134     History of Changes
Other Study ID Numbers: 2011H0329
Study First Received: January 11, 2012
Last Updated: March 28, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Ohio State University:

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on April 26, 2017