[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620717":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":25,"responsibleParty":37,"collaborators":25,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":25,"enrollmentInfo":51,"targetDuration":25,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":63,"whyStopped":25,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":25},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active TIS stimulation","EXPERIMENTAL","Participants in this group will receive transcranial temporal interference stimulation targeting the subthalamic nucleus using a frequency pair of 2000 Hz and 2130 Hz. Stimulation will be delivered twice daily at the same time for 30 minutes per session over five consecutive days（only once on the 5th day）. Stimulation intensity will be individually titrated starting from a low level and gradually increased to the maximum tolerable level. All treatments will be administered during the participant's medication \"on\" state.",[13],"Device: NervioX-1000",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham stimulation","SHAM_COMPARATOR","Participants in this group will receive sham stimulation using a frequency pair of 2000 Hz and 2000 Hz. Stimulation will be administered twice daily for 30 minutes per session over five consecutive days（only once on the 5th day） during the participant's medication \"on\" state, with current intensity individually titrated in the same manner as the active group. The sham protocol includes cutaneous sensation simulation during a 30-second ramp-up and ramp-down phase to maintain participant blinding, but does not generate an effective interference field in the deep brain target.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","NervioX-1000","All participants will receive individualized T1-weighted MRI scans for computational modeling to determine optimized electrode placement and stimulation parameters for transcranial temporal interference stimulation targeting the subthalamic nucleus. The stimulation protocol is designed to generate a focal 130 Hz interference field in the target region while minimizing cortical activation. Parameters including electrode positions and current intensity are customized based on each participant's unique neuroanatomy to ensure precise and tailored neuromodulation.",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"Zhouping Tang, PhD MD","Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 450001","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Zhouping Tang","CONTACT","+86 13971616328","ddjtzp@163.com",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Tang Zhouping","Principal Investigator","100620717","subthalamic-nucleus-stn-targeted-transcranial-temporal-interference-stimulation-tis-treats-parkinsons-disease-100620717",false,"NCT07361250","Subthalamic Nucleus (STN) Targeted Transcranial Temporal Interference Stimulation (TIS) Treats Parkinson's Disease","Evaluation of the Efficacy and Safety of Transcranial Temporal Interference Stimulation (TIS) Targeting the Subthalamic Nucleus (STN) in Parkinson's Disease: A Single-Center, Prospective, Double-Blind, Randomized Controlled Clinical Trial","TIS-STN-PD1","Inclusion Criteria:\n\n1. Age 18 years or older, no gender restriction;\n2. Diagnosis of primary Parkinson's disease according to MDS criteria: specifically, the patient must (a) exhibit parkinsonism (bradykinesia + resting tremor\u002Frigidity); (b) not meet any of the MDS absolute exclusion criteria; and (c) meet at least two MDS supportive criteria.\n3. Disease duration ≥1 year, stable condition;\n4. Hoehn-Yahr stage between 1.5 and 3, with a stable dose of levodopa or other dopaminergic medications for at least 4 weeks, responsive to levodopa-like medications, and no changes to the treatment regimen during the trial;\n5. Good compliance, with the patient and family willing to participate in the clinical trial, voluntarily sign the informed consent form, attend regular treatments and follow-ups, and accurately complete evaluation tasks.\n\nExclusion Criteria:\n\n1. Severe cognitive impairment, resulting in poor compliance due to dementia, and\u002For inability to sign the informed consent form;\n2. History of severe psychiatric disorders, patients with a Hamilton Depression Scale (HAMD) score \\>24;\n3. History of taking antipsychotic drugs, antidepressants, or other medications that may affect dopamine levels;\n4. History of seizures within the last year or a family history of epilepsy;\n5. Unable to complete MRI scanning (e.g., due to claustrophobia, or having metal implants in the body);\n6. Patients with severe heart, liver, or kidney diseases, severe hypertension, and severe orthostatic hypotension that affect their health condition;\n7. Patients with severe diabetes or severe cardio-cerebrovascular diseases that affect their health condition;\n8. Diagnosed with malignant tumors;\n9. Contraindications for non-invasive electrical stimulation, such as intracranial active implants (regardless of whether they are turned on) or passive implants that may affect electrical stimulation treatment, those who have undergone stereotactic deep brain stimulation or neurotomy, or have had any surgical procedures within the last six months that the investigator believes may affect this trial;\n10. History of traumatic brain injury;\n11. Pregnant women or women planning to become pregnant;\n12. Subjects currently participating in other clinical trials or have participated in other clinical research within the last three months without reaching primary endpoints;\n13. Patients deemed unsuitable to participate in this clinical study by the investigators.","ALL","18 Years",{"count":52,"type":53},20,"ESTIMATED","INTERVENTIONAL",[56],"NA","This is a single-center, prospective, double-blind, randomized controlled trial to evaluate the efficacy and safety of transcranial temporal interference stimulation targeting the subthalamic nucleus in patients with Parkinson's disease. It plans to enroll 20 eligible participants who will be randomly assigned in a 1:1 ratio to either the active TIS stimulation group or the sham stimulation group.",[59],"Parkinson Disease",[59,61,62],"Temporal Interference Stimulation","Subthalamic Nucleus (STN)","NOT_YET_RECRUITING","2026-01-14",{"date":66,"type":67},"2026-01-22","ACTUAL",{"date":69,"type":53},"2026-01-20",{"date":71,"type":53},"2027-06-20",{"name":39,"class":6}]