Responsive Neurostimulation For Loss Of Control Eating
Overview
- Phase
- N/A
- Intervention
- responsive neurostimulation
- Conditions
- Loss of Control Eating
- Sponsor
- University of Pennsylvania
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Incidence of Treatment-Emergent Related Adverse Events [Safety and Tolerability]
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •BMI 35-60 kg/m2
- •Failure of at least one pharmacological agent intended for weight loss or binge eating disorder (select glucagon-like-peptide 1 \[GLP-1\] receptor agonists for the treatment of type 2 diabetes, which induce clinically meaningful weight loss \[i.e., \>2% baseline weight\], qualify as agents intended for weight loss, as do glucose-dependent insulinotropic polypeptide \[GIP\]/GLP-1 agonists)
- •Failure of at least one form of behavioral therapy, such as weight loss therapy and cognitive behavioral therapy (minimum cumulative trial of 6 months)
- •Failure of gastric bypass surgery or sleeve gastrectomy surgery
- •Assessment by the study site's bariatric surgeon to rule out technical explanations for suboptimal outcome with an upper GI series within 6 months prior to consent (i.e. a pre-study referral assessment) or prior to surgery during the screening phase.
- •Presence of LOC over eating (≥4 LOC episodes per week or ≥16 episodes per month (i.e. 28 days)), as reported on the ELOCS or the EDE interview
- •Any medical (including psychiatric) conditions must be monitored actively by appropriate discipline and stable for the past 6 months. Related therapies or medications should be held stable for the study duration.
- •Surgical suitability confirmed by a psychiatric examination.
- •Subject is able to attend all scheduled clinic appointments on their own or with a caregiver.
- •Subject is willing and able to complete signaled EMA assessments.
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 requires diathermy treatments.
- •Subject requires transcranial magnetic stimulation (TMS) or electroconvulsive therapy.
- •Subject is likely to require repeat magnetic resonance imaging (MRI) after implant of the RNS Neurostimulator and Leads.
- •Subject is unable to fit into Computerized Tomography (CT) scanner (500lb upper weight limit for CT scanner).
- •Subject is pregnant or intends to become pregnant during the course of the study.
- •Subject is participating in a therapeutic investigational drug or device study.
- •Subject has medical contraindications for surgery including but not limited to severe cardiovascular, pulmonary, renal, liver, hematological disease, severe coagulopathy, or an acute infectious process.
- •Subject has evidence of neurological disorders, e.g. seizure disorder, multiple sclerosis, severe acquired brain injury, severe brain atrophy, subdural hematoma, history of hemorrhagic stroke, or other clinically relevant abnormality on preoperative imaging.
Arms & Interventions
Responsive Neurostimulation
Surgical arm. Patients expected to receive treatment.
Intervention: responsive neurostimulation
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Related Adverse Events [Safety and Tolerability]
Time Frame: 5 years
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
Count of Participants Exhibiting Overall Decrease in Loss of Control Episodes Per Week
Time Frame: 5 years
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 Eating Loss of Control Scale (ELOCS), a more standardized scale measure and better representation of LOC frequency than the Ecological Momentary Assessment (EMA).