[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06932783":3,"trial-entities:NCT06932783":100,"trial-summary:NCT06932783":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":41,"secondary_outcomes":63,"sex":64,"minimum_age":65,"maximum_age":15,"healthy_volunteers":66,"eligibility_criteria":67,"std_ages":81,"locations":84,"central_contacts":93,"overall_officials":94,"references":98,"see_also_links":99},"NCT06932783","HUM00269546","Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis","RESTORE: Remote Electrical Stimulation for Pain and Depression Treatment in Cirrhosis","ACTIVE_NOT_RECRUITING","2027-07","2026-08","2026-08-28","2025-07-22","University of Michigan","OTHER",null,"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.",[18],"Cirrhosis",[20,21,22],"Transcutaneous Electrical Acustimulation","Chronic Pain","Depression","INTERVENTIONAL","TREATMENT",[26],"NA",{"count":28,"type":29},35,"ESTIMATED",[31,36],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DEVICE","Transcutaneous Electrical Acustimulation (TEA)","Participant will apply TEA at home twice a day (approximately 45 minutes am\u002Fpm) for 8 weeks. The top electrode will be placed at ST36 (via 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 (approximately 9-10 weeks).",[33],{"type":32,"name":37,"description":38,"armGroupLabels":39},"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.\n\nAdditionally, participants will agree to allow medical records to be collected, complete various surveys and have follow-up after treatment (approximately 9-10 weeks)",[40],"TEA Sham",[42,46,49,52,56,59],{"measure":43,"description":44,"timeFrame":45},"Acceptability Questionnaire at 10 weeks","There are 7 questions that will be completed regarding the participant's experience with the study. There are six questions that participants will select strongly agree (5) - strongly disagree (1), with a range of 6-30. Additionally, participant's select from not very likely (1) -extremely likely (10).\n\nThe last scale 1-10 asks \"on a scale from 1-10, where 1 is not very likely and 10 is extremely likely, I am likely to recommend using the TEA device to a friend, colleague, or family member with cirrhosis and pain.\"","10 weeks",{"measure":47,"timeFrame":48},"Feasibility based on the proportion of participants enrolled that were contacted","Enrollment period (2 years)",{"measure":50,"timeFrame":51},"Feasibility based on the Proportion of enrolled participants that dropout (overall and during run in)","Run-in (-14 days to baseline) to 10 weeks",{"measure":53,"description":54,"timeFrame":55},"Feasibility based on time required to complete study assessments","Time will be in minutes","Screening - 10 weeks",{"measure":57,"timeFrame":58},"Proportion of questionnaires completed at baseline and the final study visit (10 weeks)","Baseline, 10 weeks",{"measure":60,"description":61,"timeFrame":62},"TEA usage during the intervention period","Time per day.","Weeks 1-8 of TEA treatment",[],"ALL","18 Years",false,{"inclusion":68,"exclusion":74,"raw_text":80},[69,70,71,72,73],"Diagnosis of cirrhosis - must meet the criteria as outlined in the protocol","Chronic pain (Patient self-reports ≥ 4 on the 0-10 scale for \\>50% of days within 3- months)","Depression (in at least half of participants) - must meet the criteria as outlined in the protocol","English speaking","Willing to use a Transcutaneous Electrical Acustimulation device",[75,76,77,78,79],"Dementia and\u002For severe cognitive impairment","Unable or unwilling to provide consent","Expected to undergo liver transplant in next 24 weeks","No email address","Deemed unsuitable by the study investigator","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* Depression (in at least half of participants) - must meet the criteria as outlined in the protocol\n* English speaking\n* Willing to use a Transcutaneous Electrical Acustimulation device\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",[82,83],"ADULT","OLDER_ADULT",[85],{"facility":13,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"Ann Arbor","Michigan","48109","United States",{"lat":91,"lon":92},42.27756,-83.74088,[],[95],{"name":96,"affiliation":13,"role":97},"Elliot Tapper, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":101,"biomarkers":102},[21,18,22],[],{"nct_id":4,"found":104,"summary":105,"prompt_version":115},true,{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is an interventional study where 30 participants will be randomly assigned to receive either active Transcutaneous Electrical Acustimulation (TEA) or sham TEA.","completed","Remote Electrical Stimulation for Pain and Depression in Cirrhosis","This study is looking into a treatment called Transcutaneous Electrical Acustimulation (TEA) for people with cirrhosis (a type of liver disease) who also experience chronic pain and depression. You would use a TEA device at home twice a day for 8 weeks. Some participants will receive the active TEA treatment, while others will receive a sham (inactive) version. The researchers want to see if this treatment is acceptable to patients and if it's practical to conduct a larger study. To join, you need to have cirrhosis, ongoing pain, and potentially depression, and be willing to use the TEA device. The study plans to enroll 30 participants.","The study measures acceptability and feasibility up to 10 weeks after the start of the treatment period.",106,"You would apply the TEA device at home twice a day for 45 minutes each time, over 8 weeks. You would also allow medical records to be collected and complete questionnaires.","Not stated in the trial record.",[33],"v2"]