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Deep Brain Stimulation for the Treatment of Obesity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01512134
First Posted: January 19, 2012
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ali Rezai, MD, The Ohio State University
  Purpose
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
Obesity Device: Deep Brain Stimulation Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Deep Brain Stimulation For Morbid, Treatment-Refractory, Obesity

Further study details as provided by Ali Rezai, MD, The 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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   22 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512134


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

Responsible Party: Ali Rezai, MD, Professor of Neurological Surgery, The Ohio State University
ClinicalTrials.gov Identifier: NCT01512134     History of Changes
Other Study ID Numbers: 2011H0329
First Submitted: January 11, 2012
First Posted: January 19, 2012
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ali Rezai, MD, The Ohio State University:
Obesity
DBS

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms