[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594275":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":47,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":29,"whyStopped":20,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Rogers Behavioral Health","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Alpha-Stim AID Intervention Arm","EXPERIMENTAL","Subjects will receive treatment as usual and non-invasive cranial electrotherapy stimulation (CES) intervention using the Alpha-Stim AID device.",[13],"Device: Alpha-Stim AID",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Alpha-Stim AID","Subjects will receive non-invasive cranial electrotherapy stimulation (CES) treatment in 20-minute group sessions taking place immediately prior to breakfast, lunch, and dinner. This study uses the Alpha-Stim AID® CES device which will be set to the highest amplitude that is tolerated by the participant (with a minimum of 200 microampere (µA) and a maximum of 500 µA stimulation) at 0.5 hertz for a duration of 20 minutes per session, 3 sessions per day, for 3 separate days of stimulation (180 minutes of stimulation total).",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Hana F Zickgraf, Ph.D.","CONTACT","262-303-0170","hana.zickgraf@rogersbh.org",[28],{"facility":5,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"RECRUITING","Oconomowoc","Wisconsin","53066","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-88.49927,43.11167,{"lat":39,"lon":38},[42,45],{"name":43,"role":24,"phone":44,"phoneExt":20,"email":26},"Hana Zickgraf, Ph.D., M.A., B.A.","610-209-7829",{"name":43,"role":46,"phone":20,"phoneExt":20,"email":20},"PRINCIPAL_INVESTIGATOR",{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[50],{"name":51,"class":52},"Electromedical Products International, Inc.","INDUSTRY","100594275","non-invasive-cranial-electrical-stimulation-for-mealtime-anxiety-in-adults-with-eating-disorders-100594275",false,"NCT07017322","Non-invasive Cranial Electrical Stimulation for Mealtime Anxiety in Adults With Eating Disorders","Investigating Non-invasive Cranial Electrotherapy Stimulation for Acute Anxiety in Inpatients With Eating Disorders","Inclusion Criteria:\n\n1. Age 18-30 years old at the time of enrollment\n2. Enrolled in Rogers Behavioral Health Eating Disorder Recovery Program Inpatient Unit at the Oconomowoc, WI clinic location\n3. Have a primary diagnosis of any DSM-5 eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder, avoidant\u002Frestrictive food intake disorder, other specified feeding or eating disorder)\n4. Ability to communicate effectively using written and spoken English\n5. Participant is eligible for mealtime anxiety support based on:\n\n   * ≤ 75% meal plan compliance\n   * Visible anxiety\u002Fdistress during program meals\n   * Engagement in compensatory behaviors or self-harm before, during, or after meals, or medical staff judge patient to be at risk of same\n\nExclusion Criteria:\n\n1. Metal in the body of any kind (e.g., braces, pacemakers, metal plates or screws, intracranial electrodes, implanted devices\u002Fdefibrillators, prostheses)\n2. Currently taking medication that reduces seizure threshold (e.g., clomipramine)\n3. Cranial pathologies (e.g., holes, plates)\n4. History of seizure or black-out concussion\n5. Pregnancy\n6. Risk of suicide\u002Fself-harm by self-strangulation with cranial electrotherapy stimulation (CES) device judged by study medical staff\n7. Participant calibrates to a stimulation level below 200 microampere (μA)","ALL","18 Years","30 Years",{"count":64,"type":65},30,"ESTIMATED","INTERVENTIONAL",[68],"NA","The study is to evaluate the feasibility of using a non-invasive brain stimulation device in a sample of inpatients with eating disorders (ED). The study will help researchers evaluate whether their device protocol is practical for eating disorder inpatients as a way to manage eating disorder and anxiety symptoms. A secondary aim of the study is to evaluate preliminary effectiveness of the protocol for reducing pre-meal anxiety during the treatment, and explore effects on eating disorder symptoms over the course of the inpatient admission.",[71,72],"Eating Disorders","Anxiety",[74,17,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"electrotherapy stimulation","cranial electrotherapy stimulation","CES","meal anxiety","Non-invasive cranial electrotherapy stimulation","Inpatient weight restoration","avoidant restrictive food intake disorder","other specified feeding or eating disorder","anorexia nervosa","bulimia nervosa","purging disorder","binge eating disorder","ARFID","OSFED","procedural anxiety","2026-08-10",{"date":91,"type":92},"2026-08-12","ACTUAL",{"date":94,"type":92},"2025-06-03",{"date":96,"type":65},"2027-11-01",{"name":5,"class":6},1]