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Neurostimulation

Responsive Neurostimulation for Binge Eating Disorder (DBSLOC Trial)

N/A
Recruiting
Research Sponsored by Casey H. Halpern
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Failure of at least one weight loss medication
Previous Gastric Bypass Surgery lead to less than 50% of excess weight lost by 2 years after surgery
Must not have
Subject is unable to fit into CT scanner (500lb upper weight limit for CT scanner).
Inability to provide informed consent to treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is to assess the function and safety of a device, with secondary objectives including feasibility.

Who is the study for?
This trial is for adults with severe obesity (BMI 40-60) who've tried at least one weight loss medication without success. They must be able to attend clinic visits, follow study rules, and premenopausal women should use birth control. It's not for those with brain implants or pacemakers, or who can't fit in a CT scanner.
What is being tested?
The trial is testing responsive neurostimulation, a device that may help control binge eating by sending electrical impulses to the brain. The focus is on how well the device works and its safety.
What are the potential side effects?
Since this involves a medical device rather than medication, side effects might include discomfort at the implant site, potential infection risk from surgery, and possible changes in mood or behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have tried at least one weight loss medication without success.
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I lost less than half of my excess weight 2 years after gastric bypass surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I weigh over 500lbs and cannot fit into a CT scanner.
Select...
I am able to understand and agree to the treatment plan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Count of Participants Exhibiting Overall Decrease in Loss of Control Episodes Per Week
Incidence of Treatment-Emergent Related Adverse Events [Safety and Tolerability]

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Responsive NeurostimulationExperimental Treatment1 Intervention
Surgical arm. Patients expected to receive treatment.

Find a Location

Who is running the clinical trial?

Casey H. HalpernLead Sponsor
1 Previous Clinical Trials
7 Total Patients Enrolled
Casey HalpernLead Sponsor
University of PennsylvaniaLead Sponsor
2,079 Previous Clinical Trials
42,721,615 Total Patients Enrolled
90 Trials studying Obesity
167,120 Patients Enrolled for Obesity

Media Library

Responsive Neurostimulation (Neurostimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03868670 — N/A
Obesity Research Study Groups: Responsive Neurostimulation
Obesity Clinical Trial 2023: Responsive Neurostimulation Highlights & Side Effects. Trial Name: NCT03868670 — N/A
Responsive Neurostimulation (Neurostimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03868670 — N/A
~0 spots leftby Jan 2025
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