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Responsive Neurostimulation For Loss Of Control Eating | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Responsive Neurostimulation For Loss Of Control Eating

NCT03868670•University of Pennsylvania

Summary

The primary objective of this trial is to assess device function and safety, with secondary objectives including the feasibility.

Detailed Description

This is a single site, early feasibility study to support development of a novel therapeutic approach for utilizing the NeuroPace RNS® System for nucleus accumbens responsive neurostimulation (NAc- RNS) to ameliorate loss of control over (LOC) eating in persons with treatment-refractory obesity, specifically those who have failed gastric bypass surgery or sleeve gastrectomy surgery. The primary objectives are to assess the safety \& feasibility \& potential efficacy of the medical device named the NeuroPace RNS® System.

Eligibility

Age

22 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•BMI 35-60 kg/m2
•Failure of at least one pharmacological agent intended for weight loss or binge eating disorder (select glucagon-like-peptide 1 \[GLP-1\] receptor agonists for the treatment of type 2 diabetes, which induce clinically meaningful weight loss \[i.e., \>2% baseline weight\], qualify as agents intended for weight loss, as do glucose-dependent insulinotropic polypeptide \[GIP\]/GLP-1 agonists)
•Failure of at least one form of behavioral therapy, such as weight loss therapy and cognitive behavioral therapy (minimum cumulative trial of 6 months)
•Failure of gastric bypass surgery or sleeve gastrectomy surgery
•Assessment by the study site's bariatric surgeon to rule out technical explanations for suboptimal outcome with an upper GI series within 6 months prior to consent (i.e. a pre-study referral assessment) or prior to surgery during the screening phase.
•Presence of LOC over eating (≥4 LOC episodes per week or ≥16 episodes per month (i.e. 28 days)), as reported on the ELOCS or the EDE interview
•Any medical (including psychiatric) conditions must be monitored actively by appropriate discipline and stable for the past 6 months. Related therapies or medications should be held stable for the study duration.
•Surgical suitability confirmed by a psychiatric examination.
•Subject is able to attend all scheduled clinic appointments on their own or with a caregiver.
•Subject is willing and able to complete signaled EMA assessments.
+5 more criteria

Exclusion Criteria

•Subject has an implanted medical device that delivers electrical energy to the brain.
•Subject has an implantable cardiac pacemaker, defibrillator, or neurostimulator.
•Subject requires diathermy treatments.
•Subject requires transcranial magnetic stimulation (TMS) or electroconvulsive therapy.
•Subject is likely to require repeat magnetic resonance imaging (MRI) after implant of the RNS Neurostimulator and Leads.
•Subject is unable to fit into Computerized Tomography (CT) scanner (500lb upper weight limit for CT scanner).
•Subject is pregnant or intends to become pregnant during the course of the study.
•Subject is participating in a therapeutic investigational drug or device study.
•Subject has medical contraindications for surgery including but not limited to severe cardiovascular, pulmonary, renal, liver, hematological disease, severe coagulopathy, or an acute infectious process.
•Subject has evidence of neurological disorders, e.g. seizure disorder, multiple sclerosis, severe acquired brain injury, severe brain atrophy, subdural hematoma, history of hemorrhagic stroke, or other clinically relevant abnormality on preoperative imaging.
+12 more criteria

Locations (2)

Stanford University

Stanford, California, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

April 10, 2019

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2028

Last Updated

February 17, 2026

Enrollment

ESTIMATED participants

Conditions

Loss of Control EatingObesity, Morbid

Interventions

responsive neurostimulation

DEVICE

Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis

NCT03868592

Obesity, Morbid

View study

RECRUITINGNA

Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

NCT05242835

ObesityObesity, Morbid

View study

RECRUITINGNA

Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Responsive Neurostimulation For Loss Of Control Eating

Inclusion Criteria

Exclusion Criteria

Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis

Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

Bariatric Surgery and Modulation of Perceived Satiety

Bariatric Surgery and Pharmacokinetics of Metoprolol

Bariatric Surgery and Pharmacokinetics of Lamotrigine