[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629872":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":60,"collaborators":31,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":31,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":89,"whyStopped":31,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Jiangsu Province Nanjing Brain Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"130 Hz TIS Group","EXPERIMENTAL","Participants receive active Temporal Interference Stimulation (TIS) with a 130 Hz envelope frequency targeting the right globus pallidus internus (GPi).",[13],"Device: Temporal Interference Stimulation (130 Hz)",{"label":15,"type":10,"description":16,"interventionNames":17},"40 Hz TIS Group","Participants receive active TIS with a 40 Hz envelope frequency targeting the right GPi.",[18],"Device: Temporal Interference Stimulation (40 Hz)",{"label":20,"type":21,"description":22,"interventionNames":23},"Sham Group","SHAM_COMPARATOR","Participants receive sham stimulation targeting the right GPi.",[24],"Device: Sham Temporal Interference Stimulation",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Temporal Interference Stimulation (130 Hz)","High-frequency sinewave currents (carrier frequency: 2000 Hz and 2130 Hz) are delivered via two pairs of scalp electrodes. The current intensity is 2-4 mA (individualized). In Phase B, stimulation lasts 30 minutes daily for 2 weeks (10 sessions).",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Temporal Interference Stimulation (40 Hz)","High-frequency sinewave currents (carrier frequency: 2000 Hz and 2040 Hz) are delivered via two pairs of scalp electrodes. Parameters are identical to the 130 Hz group except for the envelope frequency.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Sham Temporal Interference Stimulation","The device provides only a 20-second ramp-up and 20-second ramp-down of current to mimic the skin sensation of active stimulation, without continuous therapeutic stimulation.",[20],[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Weiguo Liu, MD, PhD","CONTACT","86-13914725569","wgliunbh@sina.com",[47],{"facility":48,"status":31,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":31},"Nanjing Brain Hospital (Affiliated Brain Hospital of Nanjing Medical University)","Nanjing","Jiangsu","210029","China","CN",{"type":55,"coordinates":56},"Point",[57,58],118.77778,32.06167,{"lat":58,"lon":57},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Weiguo Liu","Professor, Chief Physician","100629872","tis-for-brain-network-modulation-and-clinical-efficacy-in-parkinsons-disease-100629872",false,"NCT07480317","TIS for Brain Network Modulation and Clinical Efficacy in Parkinson's Disease","Mechanism of Temporal Interference Stimulation on Brain Networks and Its Long-term Clinical Efficacy in Parkinson's Disease","PD TIS","Inclusion Criteria:\n\n* Diagnosed with Parkinson's Disease according to the Movement Disorder Society (MDS) clinical diagnostic criteria.\n* Hoehn \\& Yahr Stage I-III (mild to moderate severity).\n* Aged 45 to 65 years.\n* Right-handed. Stable medication regimen for at least 1 hour before Phase A fMRI sessions and agreement to maintain a stable dosage during the 2-week Phase B intervention (unless clinically necessary).\n* Able to provide informed consent by the participant or a legal guardian.\n\nExclusion Criteria:\n\n* MRI contraindications, such as implanted DBS electrodes, cardiac pacemakers, or other metal implants.\n* Significant cognitive impairment (MoCA score \\\u003C 24) or severe psychiatric symptoms.\n* History of epilepsy or structural brain lesions, including severe cerebral atrophy or cerebrovascular disease.\n* Severe head tremors that would interfere with MRI scanning quality.","ALL","45 Years","65 Years",{"count":76,"type":77},75,"ESTIMATED","INTERVENTIONAL",[80],"NA","Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction. While deep brain stimulation (DBS) is effective, its invasive nature limits its application in early-stage patients. Temporal interference stimulation (TIS) is a novel non-invasive technique that can target deep brain structures like the globus pallidus internus (GPi) by using high-frequency electric fields.\n\nThis study aims to evaluate the clinical value and underlying mechanisms of TIS in PD patients. The research is divided into two phases: Phase A investigates the immediate regulatory effects of 130 Hz and 40 Hz TIS on brain networks using concurrent fMRI-TIS. Phase B is a randomized, double-blind, sham-controlled trial to assess the long-term efficacy and safety of a 2-week TIS intervention on both motor and non-motor symptoms. The results will help clarify how TIS modulates deep brain networks and its potential as a non-invasive therapy for PD.",[83],"PARKINSON DISEASE (Disorder)",[85,86,87,88],"Temporal Interference Stimulation (TIS)","Functional Magnetic Resonance Imaging (fMRI)","Non-invasive Brain Stimulation (NIBS)","Neuromodulation","NOT_YET_RECRUITING","2026-03-20",{"date":92,"type":93},"2026-03-24","ACTUAL",{"date":90,"type":77},{"date":96,"type":77},"2027-03-31",{"name":5,"class":6},1]