Responsive Neurostimulation For Loss Of Control Eating

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

Detailed Description
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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

Official Title
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Responsive Neurostimulation For Loss Of Control Eating

Conditions
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Loss of Control Eating, Obesity, Morbid

Intervention / Treatment
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* Device: responsive neurostimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Responsive Neurostimulation<br>Surgical arm. Patients expected to receive treatment. | Device: responsive neurostimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Related Adverse Events [Safety and Tolerability] | Safety of the RNS System and NAc stimulation through evaluation of AE's graded as related (vs. not related) to the intervention that will be graded based on severity. Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE | 5 years | 
| Count of Participants Exhibiting Overall Decrease in Loss of Control Episodes Per Week | This endpoint will be met if at least 50% of subjects exhibiting a decrease in the number of Loss of Control (LOC) episodes per week. LOC episodes will be assessed by the currently available standard, ecological momentary assessment (EMA) diary entries. | 5 years |