Responsive Neurostimulation For Loss Of Control Eating

Launched by UNIVERSITY OF PENNSYLVANIA · Mar 6, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for individuals who struggle with Loss of Control Eating, often linked to obesity. The study aims to evaluate the safety and effectiveness of a device designed to help manage eating behaviors. To qualify for the trial, participants typically need to have a body mass index (BMI) between 40 and 60 and have previously tried at least one weight loss medication and one form of behavioral therapy without success. They should also experience frequent episodes of Loss of Control Eating, defined as having at least four episodes per week.

Participants in the trial can expect to attend regular appointments and complete assessments related to their eating behaviors. The study seeks individuals who are stable in their medical conditions and have a support system in place. It's important for potential participants to understand that certain medical histories or conditions may exclude them from joining the trial, such as having other implanted devices or significant psychiatric issues. Overall, this study aims to offer hope for better management of eating behaviors in those who have not found success with traditional treatments.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • BMI 40-60 kg/m2
• • Failure of at least one pharmacological agent intended for weight loss or binge eating disorder (minimum trial of 6 months) (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 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.
• • Adequate social support (e.g. stable housing, identified family member or close friend as emergency contact) without acute or subacute psychosocial stressors based on screening interview
• • 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 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.