Responsive Neurostimulation For Loss Of Control Eating

Inclusion Criteria:

• BMI 35-60 kg/m2

• Failure of at least one pharmacological agent intended for weight loss or bingeeating disorder (select glucagon-like-peptide 1 [GLP-1] receptor agonists for thetreatment of type 2 diabetes, which induce clinically meaningful weight loss [i.e., >2% baseline weight], qualify as agents intended for weight loss, as doglucose-dependent insulinotropic polypeptide [GIP]/GLP-1 agonists)

• Failure of at least one form of behavioral therapy, such as weight loss therapy andcognitive 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 explanationsfor 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 screeningphase.

• 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 byappropriate discipline and stable for the past 6 months. Related therapies ormedications 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 acaregiver.

• Subject is willing and able to complete signaled EMA assessments.

• Adequate social support (e.g. stable housing, identified family member or closefriend as emergency contact) without acute or subacute psychosocial stressors basedon screening interview

• Premenopausal women must agree to use acceptable methods of birth control.

• Participants provide voluntary, decisionally capable, and appropriately informedconsent. - Subject is able to comply w/ all testing and follow-up requirementsdefined 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 thebrain.

• Subject has an implantable cardiac pacemaker, defibrillator, or neurostimulator.

• Subject requires diathermy treatments.

• Subject requires transcranial magnetic stimulation (TMS) or electroconvulsivetherapy.

• Subject is likely to require repeat magnetic resonance imaging (MRI) after implantof the RNS Neurostimulator and Leads.

• Subject is unable to fit into Computerized Tomography (CT) scanner (500lb upperweight 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 tosevere cardiovascular, pulmonary, renal, liver, hematological disease, severecoagulopathy, or an acute infectious process.

• Subject has evidence of neurological disorders, e.g. seizure disorder, multiplesclerosis, severe acquired brain injury, severe brain atrophy, subdural hematoma,history of hemorrhagic stroke, or other clinically relevant abnormality onpreoperative imaging.

• Subject has a current physical or medical condition that could affect eatingbehavior (e.g., cancer, pregnancy).

• Subject is actively using medication known to affect eating (e.g., appetitesuppressants).

• Subject has a clinically significant or unstable psychiatric condition based onpsychiatric 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 otherforms 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 drinksper occasion or any diagnosis of substance abuse/dependence disorder based on DSM-5.

• There is evidence of incipient dementia or cognitive impairment onNeuropsychological assessment by any score on memory, executive functioning,intellectual functioning, language, or visuospatial domains falling 2SD below thenormative 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 agenetic syndrome.

• Subject is a candidate for revision of their bariatric surgery due to anatomical ormedical co-morbidities that could be addressed. Of note, revision of a sleevegastrectomy to a gastric bypass for to reverse weight regain alone is lessfrequently considered a worthwhile effort as the average weight loss of such arevision is about a 10% weight loss. Thus, patients who have a sleeve and meet theReinhold classification will be included in this study.