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Responsive Neurostimulation For Loss Of Control Eating

NCT03868670 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-02-17

No results posted yet for this study

Summary

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

Conditions

  • Loss of Control Eating
  • Obesity, Morbid

Interventions

DEVICE

responsive neurostimulation

The RNS® System is a novel, implantable therapeutic device that delivers responsive neurostimulation, an advanced technology designed to continuously monitor brain electrical activity, detect abnormal electrical activity and respond by delivering imperceptible levels of electrical stimulation to normalize that activity before an individual experiences seizures. This is an Early Feasibility Study determining the safety and efficacy of NAc-RNS in the treatment of LOC eating in treatment-refractory obesity.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2028-01-01
Completion
2028-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03868670 on ClinicalTrials.gov