ACTIVE_NOT_RECRUITING

Responsive Neurostimulation For Loss Of Control Eating

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Responsive Neurostimulation For Loss Of Control Eating

Quick Facts

Study Start:2019-04-10

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03868670

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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.	* 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.

Inclusion Criteria

Exclusion 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.
* 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.

* 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.

Contacts and Locations

Study Locations (Sites)

Stanford University

Stanford, California, 94301

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19107

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-04-10

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2019-04-10

Study Completion Date2026-01-01

Terms related to this study

Additional Relevant MeSH Terms

Loss of Control Eating
Obesity, Morbid