Responsive Neurostimulation For Loss Of Control Eating

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

Inclusion Criteria:

- BMI 45-60 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.