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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

January 11, 2012
June 25, 2014
January 2012
January 2017   (final data collection date for primary outcome measure)
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).
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) which is defined as 15% loss from the initial study weight.
Complete list of historical versions of study NCT01512134 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Deep Brain Stimulation for the Treatment of Obesity
Deep Brain Stimulation For Morbid, Treatment-Refractory, Obesity

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

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Obesity
Device: Deep Brain Stimulation Device
Deep brain stimulation surgery
Other Name: Reclaim
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.
Intervention: Device: Deep Brain Stimulation Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5
January 2018
January 2017   (final data collection date for primary outcome measure)

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
Both
22 Years to 60 Years
No
Contact: Rebecca Dettorre, CCRC 614-293-8549 becky.dettorre@osumc.edu
Contact: Phuong Nguyen, MBA, CCRP 614-366-6952 phuong.nguyen2@osumc.edu
United States
 
NCT01512134
DBS for Obesity, 2011H0329
No
Ali Rezai, MD, The Ohio State University
Ali Rezai, MD
Not Provided
Principal Investigator: Ali Rezai, MD Ohio State University
Ohio State University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP