[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565802":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":22,"locations":28,"responsibleParty":42,"collaborators":11,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":11,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":11,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":30,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"University of Michigan","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Scleroderma Patients with Gastroparesis Symptoms","EXPERIMENTAL",null,[13],"Device: Transcutaneous Electrical Nerve Stimulation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Transcutaneous Electrical Nerve Stimulation","Patients will utilize the TENS device for 45 minutes, two times per day for the 4 week treatment period.",[9],[21],"TENS",[23],{"name":24,"role":25,"phone":26,"phoneExt":11,"email":27},"Dinesh Khanna, MD, MSc","CONTACT","734-936-5615","khannad@med.umich.edu",[29],{"facility":5,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":11},"RECRUITING","Ann Arbor","Michigan","48912","United States","US",{"type":37,"coordinates":38},"Point",[39,40],-83.74088,42.27756,{"lat":40,"lon":39},{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Dinesh Khanna, MD, MS","Professor of Rheumatology, University of Michigan Scleroderma Program Director","100565802","phase-1-tens-in-scleroderma-100565802",false,"NCT06646913","TENS in Scleroderma","Transcutaneous Electrical Nerve Stimulation in Scleroderma","Inclusion Criteria:\n\n1. Classification of Systemic Sclerosis according to the 2013 American College of Rheumatology and European League against Rheumatism classification criteria.\n2. Age \\>= 18 years\n3. English speaking.\n4. Participants who report moderate to severe symptoms of distension\u002Fbloating on UCLA Scleroderma Clinical Trials Consortium Gastrointestinal Tract Instrument 2.0\n5. Stable GI specific therapy including prokinetics over the last 4 weeks.\n\nExclusion Criteria:\n\n1. Pregnancy, or currently lactating.\n2. A history of major abdominal surgery (other than cholecystectomy, appendectomy, or deemed as non-major by the investigators)\n3. Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.\n4. Known allergy to adhesive ECG electrodes.\n5. Known contraindications to TEA (e.g., cardiac pacemaker, epilepsy)","ALL","18 Years",{"count":56,"type":57},16,"ESTIMATED","INTERVENTIONAL",[60],"PHASE1","The goal of this pilot study is to assess the acceptability of the transcutaneous electrical acustimulation (TEA) device in treating Scleroderma-related gastroparesis. The main objective is:\n\nTo evaluate the acceptability of TEA as an intervention for alleviating symptoms of distension and bloating in individuals diagnosed with Scleroderma.\n\nParticipants will be provided with the TEA devices that will be applied to the skin for a total of 45 minutes twice daily after meals. Participants will be asked to fill out both daily diaries and biweekly questionnaires to assess for improvement in the gastroparesis symptoms. Participants will also be asked to complete the daily diaries in addition weekly questionnaires during a 4 week post-treatment follow-up period.",[63,64,65],"Scleroderma","Gastroparesis","Systemic Sclerosis (SSc)",[21,63,64,67,68],"Pilot Study","Systemic Sclerosis","2025-06-30",{"date":71,"type":72},"2025-07-03","ACTUAL",{"date":74,"type":72},"2024-10-01",{"date":76,"type":57},"2026-05",{"name":5,"class":6},1]