[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629872":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":31,"studyPopulation":18,"armGroups":32,"interventions":50,"overallOfficials":18,"centralContacts":64,"locations":70,"responsibleParty":84,"collaborators":18,"id":88,"slug":18,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":89,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":18,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":112,"whyStopped":18,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Jiangsu Province Nanjing Brain Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Change from Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) total score.","The MDS-UPDRS Part III is a clinician-rated scale used to assess the motor signs of Parkinson's disease. It includes 18 items (33 scores total), with each item ranging from 0 (normal) to 4 (severe). The total score ranges from 0 to 132, where higher scores represent greater motor impairment.","Baseline, 2 weeks (immediately after the 10th intervention session), and 1 month (follow-up).",[14],{"measure":15,"description":16,"timeFrame":17},"Changes in Brain Network Functional Connectivity and Amplitude of Low-frequency Fluctuations (ALFF).","Assessed using resting-state fMRI to quantify the acute and long-term regulatory effects of TIS on the basal ganglia-thalamus-cortical circuit.","Baseline, 20 minutes (during concurrent TIS), and 8 minutes (immediately post-stimulation) for Phase A ; Baseline and 2 weeks for Phase B.",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":23,"observationalModel":18,"timePerspective":18,"maskingInfo":24},"RANDOMIZED","PARALLEL","This study follows a two-phase design: Phase A is a randomized crossover mechanism study (n=15). Phase B is a 3-arm parallel-group, randomized, double-blind efficacy study (n=60).","TREATMENT",{"masking":25,"maskingDescription":26,"whoMasked":27},"TRIPLE","Sham stimulation is used for blinding. It provides only a 20-second ramp-up and ramp-down of current to mimic the skin sensation of active stimulation.",[28,29,30],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","This study employs a two-phase design to systematically investigate the effects of Temporal Interference Stimulation (TIS) on Parkinson's Disease (PD).\n\nPhase A: Acute fMRI Mechanism Study (n=15) In this crossover study, participants will undergo concurrent fMRI-TIS sessions. Two frequency envelopes will be tested: 130 Hz (to mimic DBS inhibitory effects) and 40 Hz (for gamma entrainment). The fMRI protocol follows an 8-20-8 minute design: 8 minutes of baseline, 20 minutes of concurrent stimulation, and 8 minutes of post-stimulation scan . Individualized electric field modeling based on high-resolution 3D-T1 MRI will be used to target the right GPi. Acute motor changes will be assessed using the MDS-UPDRS-III scale.\n\nPhase B: Long-term Efficacy RCT (n=60) Participants will be randomly assigned to one of three parallel groups: 130 Hz TIS, 40 Hz TIS, or Sham stimulation. The intervention consists of 30-minute daily sessions for 2 weeks (10 sessions total).\n\nActive Groups: TIS targeting the right GPi with individualized electrode configurations.\n\nSham Group: 20-second ramp-up and ramp-down to mimic skin sensation without continuous stimulation.\n\nClinical assessments including motor function (MDS-UPDRS), cognition (MoCA), mood (HAMD\u002FHAMA), and sleep (PDSS-2) will be conducted at baseline, after the 2-week intervention, and at a 1-month follow-up . Long-term neuroplasticity will also be evaluated using multi-modal MRI post-intervention.",[33,39,44],{"label":34,"type":35,"description":36,"interventionNames":37},"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).",[38],"Device: Temporal Interference Stimulation (130 Hz)",{"label":40,"type":35,"description":41,"interventionNames":42},"40 Hz TIS Group","Participants receive active TIS with a 40 Hz envelope frequency targeting the right GPi.",[43],"Device: Temporal Interference Stimulation (40 Hz)",{"label":45,"type":46,"description":47,"interventionNames":48},"Sham Group","SHAM_COMPARATOR","Participants receive sham stimulation targeting the right GPi.",[49],"Device: Sham Temporal Interference Stimulation",[51,56,60],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":18},"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).",[34],{"type":52,"name":57,"description":58,"armGroupLabels":59,"otherNames":18},"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.",[40],{"type":52,"name":61,"description":62,"armGroupLabels":63,"otherNames":18},"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.",[45],[65],{"name":66,"role":67,"phone":68,"phoneExt":18,"email":69},"Weiguo Liu, MD, PhD","CONTACT","86-13914725569","wgliunbh@sina.com",[71],{"facility":72,"status":18,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":18},"Nanjing Brain Hospital (Affiliated Brain Hospital of Nanjing Medical University)","Nanjing","Jiangsu","210029","China","CN",{"type":79,"coordinates":80},"Point",[81,82],118.77778,32.06167,{"lat":82,"lon":81},{"type":85,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Weiguo Liu","Professor, Chief Physician","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":99,"type":100},75,"ESTIMATED","INTERVENTIONAL",[103],"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.",[106],"PARKINSON DISEASE (Disorder)",[108,109,110,111],"Temporal Interference Stimulation (TIS)","Functional Magnetic Resonance Imaging (fMRI)","Non-invasive Brain Stimulation (NIBS)","Neuromodulation","NOT_YET_RECRUITING","2026-03-20",{"date":115,"type":116},"2026-03-24","ACTUAL",{"date":113,"type":100},{"date":119,"type":100},"2027-03-31",{"name":5,"class":6},1]