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Deep Brain Stimulation for the Treatment of Obesity

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ClinicalTrials.gov Identifier: NCT01512134
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Ali Rezai, MD, Ohio State University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Device: Deep Brain Stimulation Device Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Deep Brain Stimulation For Morbid, Treatment-Refractory, Obesity
Study Start Date : January 2012
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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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
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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
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United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ali Rezai, MD
Investigators
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Principal Investigator: Ali Rezai, MD Ohio State University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ali Rezai, MD, Professor of Neurological Surgery, Ohio State University
ClinicalTrials.gov Identifier: NCT01512134    
Other Study ID Numbers: 2011H0329
First Posted: January 19, 2012    Key Record Dates
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, Ohio State University:
Obesity
DBS
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight