[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656113":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":11,"studyPopulation":11,"armGroups":34,"interventions":47,"overallOfficials":56,"centralContacts":60,"locations":66,"responsibleParty":105,"collaborators":108,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":115,"sex":121,"minAge":122,"maxAge":11,"enrollmentInfo":123,"targetDuration":11,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":132,"overallStatus":136,"whyStopped":11,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"University of Michigan","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Retention",null,"Approximately day -14, day 1, and day 56",{"measure":14,"description":15,"timeFrame":16},"Device adherence","Reported as percent, reported from device utilization logs","Approximately week 8",{"measure":18,"description":19,"timeFrame":16},"Questionnaire completion","Reported as percent",{"measure":21,"description":22,"timeFrame":23},"Acceptability of Intervention Measure (AIM) score","AIM is a 6-item study-specific Likert battery with scores ranging from 0-5. Higher scores indicate lower acceptability.","Approximately week 8 and week 12",{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":11,"timePerspective":11,"maskingInfo":29},"RANDOMIZED","PARALLEL","This is an 8-week, randomized, double-blind, sham-controlled pilot trial of TEA across two academic medical centers, in preparation for a subsequent multicenter efficacy trial.","TREATMENT",{"masking":30,"maskingDescription":11,"whoMasked":31},"DOUBLE",[32,33],"PARTICIPANT","OUTCOMES_ASSESSOR",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"Transcutaneous Electrical Acustimulation (TEA)","EXPERIMENTAL","Participants will have a two-week run-in period and then 8 weeks of treatment.",[40],"Device: Transcutaneous Electrical Acustimulation (TEA)",{"label":42,"type":43,"description":44,"interventionNames":45},"TEA Sham","SHAM_COMPARATOR","Participants will have a two-week run-in period and then 8 weeks of sham treatment.",[46],"Device: Sham Transcutaneous Electrical Acustimulation (TEA)",[48,52],{"type":49,"name":36,"description":50,"armGroupLabels":51,"otherNames":11},"DEVICE","Participant will apply TEA at home twice a day (approximately 45 minutes am\u002Fpm) for 8 weeks. The top electrode will be placed at an acupuncture point and the electrode patch will be placed vertically.\n\nAdditionally, participants will agree to allow medical records to be collected, complete various surveys and have follow-up after treatment.",[36],{"type":49,"name":53,"description":54,"armGroupLabels":55,"otherNames":11},"Sham Transcutaneous Electrical Acustimulation (TEA)","Participant will apply sham TEA at home twice a day (approximately 45 minutes am\u002Fpm) for 8 weeks. Sham TEA will be performed via one point on the leg and not on any meridian or acupoints that were used in previous gastrointestinal studies and did not yield any significant effects. Additionally, participants will agree to allow medical records to be collected, complete various surveys and have follow-up after treatment",[42],[57],{"name":58,"affiliation":5,"role":59},"Elliot Tapper, MD","PRINCIPAL_INVESTIGATOR",[61],{"name":62,"role":63,"phone":64,"phoneExt":11,"email":65},"Andrea MacMichael","CONTACT","734-232-4182","amacmi@umich.edu",[67,84],{"facility":5,"status":11,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Ann Arbor","Michigan","48109","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-83.74088,42.27756,{"lat":77,"lon":76},[80,83],{"name":81,"role":63,"phone":64,"phoneExt":11,"email":82},"Melanie Tapper","etapper@umich.edu",{"name":58,"role":59,"phone":11,"phoneExt":11,"email":11},{"facility":85,"status":11,"city":86,"state":87,"zip":88,"country":71,"countryCode":72,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":74,"coordinates":90},[91,92],-75.16362,39.95238,{"lat":92,"lon":91},[95,99,103],{"name":96,"role":63,"phone":97,"phoneExt":11,"email":98},"Richard Mason, PharmD","215-349-8986","Richard.Mason@pennmedicine.upenn.edu",{"name":100,"role":63,"phone":101,"phoneExt":11,"email":102},"Jacqueline Theroux, MPH","215-662-3904","Jacqueline.Theroux@pennmedicine.upenn.edu",{"name":104,"role":59,"phone":11,"phoneExt":11,"email":11},"Marina Serper, MD, MS",{"type":59,"investigatorFullName":106,"investigatorTitle":107,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Elliot B. Tapper","Professor of Hepatology and Associate Professor of Internal Medicine",[109,112],{"name":110,"class":111},"National Center for Complementary and Integrative Health (NCCIH)","NIH",{"name":85,"class":6},"100656113","chronic-pain-optimization-and-management-for-relief-and-functionality-with-tea-in-cirrhosis-100656113",false,"NCT07820917","Chronic Pain Optimization and Management for Relief and Functionality With TEA in Cirrhosis","COMFORT: Chronic Pain Optimization and Management for Relief and Functionality With TEA in Cirrhosis","COMFORT","Inclusion Criteria:\n\n* Diagnosis of cirrhosis - must meet the criteria as outlined in the protocol\n* Chronic pain (Patient self-reports ≥ 4 on the 0-10 scale for \\>50% of days within 3- months)\n* Willing to use a Transcutaneous Electrical Acustimulation (TEA) device\n* Has access to Wi-Fi or a data plan\n* Has access to a laptop, computer, tablet, or smartphone\n\nExclusion Criteria:\n\n* Dementia and\u002For severe cognitive impairment\n* Unable or unwilling to provide consent\n* Expected to undergo liver transplant in next 24 weeks\n* No email address\n* Deemed unsuitable by the study investigator\n* Model for End-Stage Liver Diseas (MELD) score \\>25, or total bilirubin \\>4.0 in a patient on hemodialysis\n* Recent hospitalization (\\>24 hours) or episode of hepatic encephalopathy within the preceding 30 days\n* Implanted pacemaker\u002Fdefibrillator, spinal implant, or cochlear implant\n* Known allergy to adhesive tape\u002Felectrode materials\n* Current active suicidal ideation, endorsed at screening (see Section 8.6)\n* Currently pregnant (self-reported)","ALL","18 Years",{"count":124,"type":125},100,"ESTIMATED","INTERVENTIONAL",[128],"NA","This study is being done to better understand how the study team can treat pain for people with cirrhosis and depression.\n\nEnrolled participants on this feasibility study will be randomized to Transcutaneous Electrical Acustimulation (TEA) or sham TEA.",[131],"Cirrhosis",[133,134,135],"Transcutaneous Electrical Acustimulation","Chronic Pain","Depression","NOT_YET_RECRUITING","2026-09-14",{"date":139,"type":140},"2026-09-16","ACTUAL",{"date":142,"type":125},"2026-09",{"date":144,"type":125},"2029-09",{"name":5,"class":6},2]