[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Kezhong Zhang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100567202","neuroprotective-effects-of-long-term-tavns-in-early-parkinsons-disease-patients-100567202",false,"NCT06665113","Neuroprotective Effects of Long-term TaVNS in Early Parkinson's Disease Patients","A Double-blinded, Randomized, Parallel-group, Superiority Study to Explore the Neuroprotective Effects of Long-term Transcutaneous Auricular Vagus Nerve Stimulation(taVNS) in Early Parkinson's Disease(PD) Patients","NLTVNSPD","Inclusion Criteria:\n\n1. Age 55-75 years.\n2. Clinically diagnosed Idiopathic Parkinson's disease patients according to the 2016 Chinese diagnostic criteria for Parkinson's disease.\n3. Hoehn and Yahr (H\\&Y) stage ≤ 2.5 at medication initiation.\n4. Parkinson's disease duration ≤ 3 years.\n5. Receiving standard anti-Parkinson's disease medication treatment.\n\nExclusion Criteria:\n\n1. Patients with cognitive impairment (MMSE \\\u003C 24 and\u002For MoCA \\\u003C 26) or mental illnesses, or those unable to cooperate for other reasons.\n2. Use of neuroprotective medications within 90 days prior to baseline, including monoamine oxidase B inhibitors (rasagiline, selegiline), certain dopamine receptor agonists (ropinirole), and GLP-1 receptor agonists such as Exenatide and NLY-01.\n3. Use of any medications that may affect dopamine metabolism and\u002For dopamine receptors within 90 days prior to baseline, including typical and atypical antipsychotics, metoclopramide, α-methyl-dopa, flunarizine, apomorphine, amphetamine derivatives, bupropion, buprenorphine, cocaine, meperidine, methamphetamine, norephedrine, phentermine, modafinil, methylphenidate, procyclidine, reserpine, phenylpropanolamine, or MAO-A inhibitors.\n4. Previous treatment with vagus nerve stimulation.\n5. MRI contraindications (e.g., claustrophobia unresponsive to comfort or low-dose anxiolytics, dental implants) or MRI scans indicating clinically significant abnormalities in the brain, including but not limited to past hemorrhages or infarcts \\> 1 cm³ or \\> 3 lacunar infarcts.\n6. Contraindications for taVNS, such as patients with cardiac pacemakers or a history of DBS surgery, or those planning surgery during the trial; ear conditions, such as tympanic membrane perforation.\n7. Atypical or secondary Parkinsonian syndromes, including but not limited to those caused by trauma, brain tumors, infections, cerebrovascular diseases, or other neurological disorders, or symptoms confirmed by the investigator as drug, chemical, or toxin-related.\n8. Previous history of stroke or intracranial mass lesions.\n9. Patients with existing or potential cardiovascular diseases.\n10. Ophthalmic diseases affecting eye movements.\n11. Any neurological disorders other than Parkinsonian motor symptoms that interfere with gait or balance (e.g., chronic pain) or musculoskeletal injuries (e.g., fractures, stroke sequelae).\n12. Severe organic diseases, such as late-stage tumors, with a life expectancy of less than 2 years.\n13. Concurrent participation in other clinical trials.\n14. Inability to receive the required treatment and follow-up due to geographic reasons.\n15. Any subject with an upper limb UPDRS tremor score of 3 or higher.\n16. Patients with a history of PD-related freezing episodes or falls.","ALL","55 Years","75 Years",{"count":21,"type":22},12,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is a randomized, double-blind, controlled trial exploring the effects of long-term taVNS intervention in patients with early-stage Parkinson's disease.",[28],"Parkinson Disease, Idiopathic",[28,30],"Vagus Nerve Stimulation","RECRUITING","2025-01-12",{"date":34,"type":35},"2025-01-14","ACTUAL",{"date":37,"type":35},"2024-12-23",{"date":39,"type":22},"2026-06",{"name":41,"class":42},"Kezhong Zhang","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":19,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100564009","ameliorating-effects-and-mechanisms-of-tavns-on-constipation-in-pd-patients-100564009","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.","40 Years",{"count":53,"type":22},30,[25],"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.",[28,57],"Constipation",[59,60],"constipation","Parkinson's disease","NOT_YET_RECRUITING","2024-10-03",{"date":64,"type":35},"2024-10-04",{"date":66,"type":22},"2024-10-15",{"date":68,"type":22},"2024-12-30",{"name":41,"class":42},""]