[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564009":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":26,"responsibleParty":41,"collaborators":26,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":26,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":26,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":67,"whyStopped":26,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":26},{"fullName":5,"class":6},"The First Affiliated Hospital with Nanjing Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Transcutaneous auricular vagus nerve stimulation","EXPERIMENTAL","For Experimental Arm, active transcutaneous auricular vagus nerve stimulation, Patients underwent 28 consecutive daily sessions of taVNS.",[13],"Device: active Transcutaneous auricular vagus nerve stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Transcutaneous auricular vagus nerve stimulation","SHAM_COMPARATOR","For sham transcutaneous auricular vagus nerve stimulation arm, Sham Comparator, patients underwent 28 consecutive daily sessions of sham-taVNS (the electrodes were fixed at the the left earlobe).",[19],"Device: sham Transcutaneous auricular vagus nerve stimulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","active Transcutaneous auricular vagus nerve stimulation","Transcutaneous auricular vagus nerve stimulation was conducted by transcutaneous electrical stimulation therapy instrument to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs, twice a day, 30 minutes each time.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"sham Transcutaneous auricular vagus nerve stimulation","In the sham stimulation group, the electrodes were fixed at the left earlobe with the same stimulus parameters. Stimulation parameters: frequency = 20 Hz; pulse width = 500 μs, twice a day, 30 minutes each time.",[15],[32],{"name":33,"affiliation":5,"role":34},"Kezhong Zhang","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Kezhong Zhang, Professor","CONTACT","13770840575","kezhong_zhang1969@126.com",{"type":42,"investigatorFullName":33,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Professor","100564009","ameliorating-effects-and-mechanisms-of-tavns-on-constipation-in-pd-patients-100564009",false,"NCT06623591","Ameliorating Effects and Mechanisms of TaVNS on Constipation in PD Patients.","Ameliorating Effects and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Constipation in Parkinson's Disease Patients: a Randomized, Double-blind Clinical Trial","Inclusion Criteria:\n\n1. aged 40-70 years;\n2. had a PD diagnosis designated by movement disorder neurologists (Ke-zhong Zhang and Yong-sheng Yuan) according to Movement Disorder Society Clinical Diagnostic Criteria;\n3. fulfilled Rome IV criteria for functional constipation, including having \\\u003C 3 spontaneous bowel movements (SBM; i.e., not induced by rescue medication) per week for the past 3 months with symptom duration of at least 6 months;\n4. stable initiation of PD medications, leastways 3 month before this investigation; (5) provided written informed consent.\n\nExclusion Criteria:\n\n1. a history of previous abdominal surgery (other than appendectomy);\n2. the presence of carcinoma;\n3. any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, or spinal cord injury;\n4. taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors;\n5. a serious concomitant disease of the heart, liver, kidney, or diabetes;\n6. pregnancy or lactation;\n7. participating in another trial or enrolled in a trial during the past month;\n8. an allergic reaction to surface electrodes.","ALL","40 Years","75 Years",{"count":55,"type":56},30,"ESTIMATED","INTERVENTIONAL",[59],"NA","The investigators intend to conduct a randomized, double-blind, sham-stimulation-controlled experiment, incorporating various clinical scales, gastrointestinal electrogram, and high-resolution anorectal manometry (HRAM), to investigate the improvement effect of taVNS on constipation symptoms in PD patients.",[62,63],"Parkinson Disease, Idiopathic","Constipation",[65,66],"constipation","Parkinson's disease","NOT_YET_RECRUITING","2024-10-03",{"date":70,"type":71},"2024-10-04","ACTUAL",{"date":73,"type":56},"2024-10-15",{"date":75,"type":56},"2024-12-30",{"name":33,"class":6}]