NCT03868670

Responsive Neurostimulation For Loss Of Control Eating

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Loss of Control Eating
• Obesity, Morbid

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-10
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2019-03-11
• Last updated: 2026-02-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study