Deep Brain Stimulation for the Treatment of 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.
|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|
- 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).
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512134
|Contact: Rebecca Dettorre, CCRCfirstname.lastname@example.org|
|Contact: Phuong Nguyen, MBA, CCRPemail@example.com|
|United States, Ohio|
|The Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Rebecca Dettorre, CCRC 614-293-8549 firstname.lastname@example.org|
|Sub-Investigator: Bradley Needleman, MD|
|Principal Investigator:||Ali Rezai, MD||Ohio State University|