Responsive Neurostimulation For Loss Of Control Eating (DBSLOC)

University of Pennsylvania

Status: Enrolling

Conditions: Loss of Control Eating; Obesity, Morbid

Treatments: Device: responsive neurostimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03868670

IRB-46563

Details and patient eligibility

About

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

Full 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. The primary objectives are to assess the safety & feasibility & potential efficacy of the medical device named the NeuroPace RNS® System

Enrollment: 6 estimated patients

Sex: All

Ages: 22 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI 40-60 kg/m2
• 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
• Significant Loss of Control over eating
• Subject is able to attend all scheduled clinic appointments on their own or with a caregiver.
• Premenopausal women must agree to use acceptable methods of birth control.
• Participants provide voluntary, decisionally capable, and appropriately informed consent.
• Subject is able to comply w/ all testing and follow-up requirements defined by the study protocol.
• Participant has no immediate plan for relocation beyond 6 hours of the study site.
• Proficiency with the English language.

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 is likely to require repeat MR imaging after implant of the RNS Neurostimulator and Leads.
• Subject is unable to fit into CT scanner (500lb upper weight limit for CT scanner).
• Inability to provide informed consent to treatment.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Responsive Neurostimulation

Experimental group

Description:

Surgical arm. Patients expected to receive treatment.

Treatment:

Device: responsive neurostimulation