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CompletedNCT01512134Updated Mar 30, 2017

Deep Brain Stimulation for the Treatment of Obesity

An interventional study of Deep Brain Stimulation Device in Obesity, sponsored by Ali Rezai, MD. Completed at 1 site in United States. Open to participants aged 22 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-03-30.

Sponsored by Ali Rezai, MD · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
22 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity

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Keywords

  • Obesity
  • DBS
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's enrollment of 3 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Ali Rezai, MD is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
22 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • 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

Interventions

  • DeviceDeep Brain Stimulation Device

    Deep brain stimulation surgery

    Also known as: Reclaim

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What researchers measure

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).

    Time frame: 2 years

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Study locations

1 site
  • The Ohio State University Medical Center
    Columbus, Ohio 43210, United States
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References and documents

Publications

  • 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. PubMed 32140113 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01512134
Lead sponsor
Ali Rezai, MD
Responsible party
Ali Rezai, MD (Professor of Neurological Surgery, Ohio State University) — Sponsor-investigator
First posted
Jan 19, 2012
Start date
Jan 2012
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Mar 30, 2017

Study contacts

Ali Rezai, MD
principal investigator · Ohio State University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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