Responsive Neurostimulation For Loss Of Control Eating

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.
• •Subject has a current physical or medical condition that could affect eating behavior (e.g., cancer, pregnancy).
• •Subject is actively using medication known to affect eating (e.g., appetite suppressants).
• •Subject has a clinically significant or unstable psychiatric condition based on psychiatric screening interview.
• •Subject has a clinical diagnosis (past or present) of severe anxiety disorder, severe major depression, psychosis, or anorexia based on diagnostic interview.
• •Subject has any lifetime history of suicide attempt, intent or engagement in other forms of self-harm behaviors (e.g. cutting).
• •Subject has a history of drug abuse or dependence, including nicotine and alcohol, within the preceding 24 months.
• •Subject has current use of alcohol at the rate of \> 14 drinks per week or \> 4 drinks per occasion or any diagnosis of substance abuse/dependence disorder based on DSM-5.
• •There is evidence of incipient dementia or cognitive impairment on Neuropsychological assessment by any score on memory, executive functioning, intellectual functioning, language, or visuospatial domains falling 2SD below the normative mean.
• •There is evidence of comprehension difficulties (Token Test \<36).
• •Subject is unable to provide informed consent to treatment.
• •Obesity is secondary to another medical condition, a medication side effect, or a genetic syndrome.
• •Subject is a candidate for revision of their bariatric surgery due to anatomical or medical co-morbidities that could be addressed. Of note, revision of a sleeve gastrectomy to a gastric bypass for to reverse weight regain alone is less frequently considered a worthwhile effort as the average weight loss of such a revision is about a 10% weight loss. Thus, patients who have a sleeve and meet the Reinhold classification will be included in this study.