Deep Brain Stimulation for the Treatment of Obesity

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Ali Rezai, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01512134
First received: January 11, 2012
Last updated: June 25, 2014
Last verified: June 2014
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation For Morbid, Treatment-Refractory, Obesity

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Percentage of excess weight loss [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    The primary outcome measure at the conclusion of the study will be percent of excess weight loss (EWL).


Estimated Enrollment: 5
Study Start Date: January 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (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

Ages Eligible for Study:   22 Years to 60 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01512134

Contacts
Contact: Rebecca Dettorre, CCRC 614-293-8549 becky.dettorre@osumc.edu
Contact: Phuong Nguyen, MBA, CCRP 614-366-6952 phuong.nguyen2@osumc.edu

Locations
United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Rebecca Dettorre, CCRC    614-293-8549    becky.dettorre@osumc.edu   
Sub-Investigator: Bradley Needleman, MD         
Sponsors and Collaborators
Ali Rezai, MD
Investigators
Principal Investigator: Ali Rezai, MD Ohio State University
  More Information

No publications provided

Responsible Party: Ali Rezai, MD, Professor of Neurological Surgery, The Ohio State University
ClinicalTrials.gov Identifier: NCT01512134     History of Changes
Other Study ID Numbers: DBS for Obesity, 2011H0329
Study First Received: January 11, 2012
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University:
Obesity
DBS

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

ClinicalTrials.gov processed this record on July 23, 2014