Deep Brain Stimulation for the Treatment of Obesity
Deep Brain Stimulation For Morbid, Treatment-Refractory, Obesity
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jan 2012
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 11, 2012
CompletedFirst Posted
Study publicly available on registry
January 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedMarch 30, 2017
March 1, 2017
4.8 years
January 11, 2012
March 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of excess weight loss
The primary outcome measure at the conclusion of the study will be percent of excess weight loss (EWL).
2 years
Study Arms (1)
DBS Surgery
EXPERIMENTALAll patients enrolled will undergo DBS implantation in the targeted region to assess the safety of the procedure and the efficacy through weight loss.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ali Rezai, MDlead
Study Sites (1)
The Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Related Publications (1)
Weichart ER, Sederberg PB, Sammartino F, Krishna V, Corrigan JD, Rezai AR. Cognitive Task Performance During Titration Predicts Deep Brain Stimulation Treatment Efficacy: Evidence From a Case Study. Front Psychiatry. 2020 Feb 19;11:30. doi: 10.3389/fpsyt.2020.00030. eCollection 2020.
PMID: 32140113DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Rezai, MD
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Neurological Surgery
Study Record Dates
First Submitted
January 11, 2012
First Posted
January 19, 2012
Study Start
January 1, 2012
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
March 30, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share