[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652408":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":50,"centralContacts":51,"locations":57,"responsibleParty":74,"collaborators":50,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":50,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":50,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":60,"whyStopped":50,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"STN-tTIS Once Weekly","EXPERIMENTAL","Participants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) once weekly for 2 weeks in addition to stable antiparkinsonian medication.",[13,14],"Device: STN-tTIS Once Weekly","Drug: Standard Antiparkinsonian Medication",{"label":16,"type":10,"description":17,"interventionNames":18},"STN-tTIS Twice Weekly","Participants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) twice weekly for 2 weeks in addition to stable antiparkinsonian medication.",[19,14],"Device: STN-tTIS Twice Weekly",{"label":21,"type":10,"description":22,"interventionNames":23},"STN-tTIS Five Times Weekly","Participants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) five times weekly for 2 weeks in addition to stable antiparkinsonian medication.",[24,14],"Device: STN-tTIS Five Times Weekly",{"label":26,"type":27,"description":28,"interventionNames":29},"Standard Medical Therapy Alone","ACTIVE_COMPARATOR","Participants continue their stable antiparkinsonian medication regimen for 2 weeks without additional STN-tTIS.",[14],[31,37,41,45],{"type":32,"name":9,"description":33,"armGroupLabels":34,"otherNames":35},"DEVICE","Participants receive subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) once weekly for 2 weeks. Each stimulation session lasts 20 minutes. Two high-frequency alternating currents at 2000 Hz and 2130 Hz are delivered through two pairs of scalp electrodes, generating a 130-Hz temporal interference envelope targeting the subthalamic nucleus. Stable antiparkinsonian medication is maintained throughout the intervention period.",[9],[36],"Transcranial Temporal Interference Stimulation",{"type":32,"name":16,"description":38,"armGroupLabels":39,"otherNames":40},"Participants receive subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) twice weekly for 2 weeks. Each stimulation session lasts 20 minutes. Two high-frequency alternating currents at 2000 Hz and 2130 Hz are delivered through two pairs of scalp electrodes, generating a 130-Hz temporal interference envelope targeting the subthalamic nucleus. Stable antiparkinsonian medication is maintained throughout the intervention period.",[16],[36],{"type":32,"name":21,"description":42,"armGroupLabels":43,"otherNames":44},"Participants receive subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) five times weekly for 2 weeks. Each stimulation session lasts 20 minutes. Two high-frequency alternating currents at 2000 Hz and 2130 Hz are delivered through two pairs of scalp electrodes, generating a 130-Hz temporal interference envelope targeting the subthalamic nucleus. Stable antiparkinsonian medication is maintained throughout the intervention period.",[21],[36],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","Standard Antiparkinsonian Medication","Participants continue their stable antiparkinsonian medication regimen throughout the 2-week study intervention period. No additional STN-tTIS is administered.",[21,9,16,26],null,[52],{"name":53,"role":54,"phone":55,"phoneExt":50,"email":56},"Chencheng Zhang, MD, PHD","CONTACT","13381827024","i@cchang.org",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","RECRUITING","Shanghai","Shanghai Municipality","200025","China","CN",{"type":67,"coordinates":68},"Point",[69,70],121.45806,31.22222,{"lat":70,"lon":69},[73],{"name":53,"role":54,"phone":55,"phoneExt":50,"email":56},{"type":75,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100652408","stn-ttis-with-different-intervention-intervals-versus-standard-medical-treatment-for-parkinsons-disease-100652408",false,"NCT07774312","STN-tTIS With Different Intervention Intervals Versus Standard Medical Treatment for Parkinson's Disease","STN-targeted Temporal Interference Stimulation With Different Intervention Intervals Versus Standard Medical Treatment for Parkinson's Disease: A Multicenter, Randomized, Controlled Trial","Inclusion Criteria:\n\n* 1.Aged 50-85 years, male or female.\n* 2.Diagnosed with idiopathic Parkinson disease (PD) in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Parkinson's Disease (4th Edition), with a confirmed diagnosis for at least 6 months and a stable condition, defined as no significant deterioration or major medication adjustment within the past month.\n* 3.Receiving stable doses of antiparkinsonian medication (e.g., levodopa or dopamine agonists) and willing to maintain the medication regimen during the study.\n* 4.Hoehn and Yahr stage 1-3 in the medication ON state.\n* 5.Baseline MDS-UPDRS Part III total score ≥20 in the medication ON state.\n* 6.No history of non-invasive neuromodulation therapy, or discontinuation of such therapy for at least 3 months before enrollment if previously received.\n* 7.Normal cognitive function (MoCA score ≥24) and able to cooperate with tTIS intervention, clinical scale assessments, and basic smartphone- and smartwatch-assisted home-based motor self-assessments.\n* 8.Able and willing to provide written informed consent and complete all required study procedures and follow-up assessments.\n\nExclusion Criteria:\n\n* 1.Other neurological disorders that may affect motor or cognitive function.\n* 2.Contraindications to magnetic resonance imaging (MRI), such as claustrophobia.\n* 3.History of taking antipsychotics, antidepressants, or other medications affecting dopamine levels.\n* 4.Psychiatric disorders (e.g., depression or schizophrenia), substance abuse, or alcohol dependence.\n* 5.Implanted medical devices (e.g., pacemaker or defibrillator), metal implants in the cranium or spine, a personal or family history of epilepsy, or severe skull defects.\n* 6.Previous deep brain stimulation (DBS) or other intracranial implantation surgery, or participation in another Parkinson disease clinical trial within the past 3 months.","ALL","50 Years","85 Years",{"count":87,"type":88},60,"ESTIMATED","INTERVENTIONAL",[91],"NA","The goal of this clinical trial is to compare the efficacy and safety of different Intervention Intervals of subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) in patients with Parkinson disease.\n\nPrevious studies suggest that STN-tTIS may improve motor symptoms in people with Parkinson disease. However, most previous studies evaluated only one stimulation session. It remains unclear how often STN-tTIS should be administered during a repeated treatment course and whether shorter intervention intervals stimulation produces greater or longer-lasting improvement without increasing adverse events.\n\nThe main questions this study aims to answer are:\n\n1. Does STN-tTIS administered five times weekly improve motor symptoms more than standard medication treatment alone at the end of the 2-week treatment period?\n2. Do once-weekly, twice-weekly, and five-times-weekly STN-tTIS produce different changes in motor symptoms?\n3. Does the STN-tTIS intervention intervals influence how long its effects persist after treatment?\n4. Do the different intervention intervals have different effects on non-motor symptoms, quality of life, cognitive function, and safety?\n\nParticipants will be randomly assigned to receive STN-tTIS once weekly, twice weekly, or five times weekly for 2 weeks, or to continue standard antiparkinsonian medication without additional stimulation. All participants will maintain a stable medication regimen during the study. Their motor and non-motor symptoms will be assessed during the treatment period and during a subsequent 2-week follow-up period.",[94],"Parkinson's Disease (PD)",[96,36,97],"Subthalamic nucleus","Intervention Intervals","2026-08-20",{"date":100,"type":101},"2026-08-21","ACTUAL",{"date":103,"type":101},"2026-07-27",{"date":105,"type":88},"2027-04-15",{"name":5,"class":6},1]