Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2025-12-30 @ 8:55 AM
Study NCT ID:
NCT06980935
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-20
First Post:
2025-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
STN-tTIS Modulates Parkinson Motor Symptoms With and Without Medications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-05-18', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-18', 'studyFirstSubmitDate': '2025-05-11', 'studyFirstSubmitQcDate': '2025-05-18', 'lastUpdatePostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MDS-UPDRS-Ⅲ scores', 'timeFrame': 'pre-intervention, immediately after the intervention', 'description': 'The score range for MDS-UPDRS-Ⅲ is from 0 to 132. Minimum Value: 0, indicating no motor impairment. Maximum Value: 132, indicating the most severe motor impairment.\n\nHigher scores on the MDS-UPDRS-Ⅲ indicate worse outcomes, as they reflect greater severity of motor symptoms.'}], 'secondaryOutcomes': [{'measure': 'MDS-UPDRS-Ⅲ sub-scores', 'timeFrame': 'pre-intervention, immediately after the intervention', 'description': "The MDS-UPDRS-Ⅲ assesses motor symptoms in Parkinson's disease through sub-scores:\n\nTremor Sub-score: Items 15-18; range 0-16. Higher scores indicate more severe tremors.\n\nRigidity Sub-score: Item 3; range 0-12. Higher scores reflect greater rigidity. Bradykinesia Sub-score: Items 2, 4-9, and 14; range 0-40. Higher scores indicate more severe slowness of movement.\n\nAxial Sub-score: Items 1 and 9-13; range 0-24. Higher scores suggest more significant axial impairments."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subthalamic nucleus', 'transcranial temporal interference stimulation', 'MDS-UPDRS-Ⅲ'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the immediate effects of individualized 130 Hz STN-tTIS(Subthalamic Nucleus - transcranial Temporal Interference Stimulation)on motor symptoms in early-to-mid-stage PD patients during both medication "on" and "off" states. The main questions it aims to answer are:\n\n1. Does the therapeutic effect of STN - tTIS relate to medication?\n2. The degree of improvement in motor symptoms of Parkinson\'s disease patients after STN - tTIS therapy under different medication conditions.\n\nResearchers compared the MDS - UPDRS - III improvement scores of tTIS therapy in the "on" and "off" medication phases to see if tTIS could work of independently medication.\n\n1. Visit the clinic once every 1 weeks for therapy and test.\n2. Record their symptoms and scores.', 'detailedDescription': 'This clinical trial aims to explore whether individualized 130 Hz subthalamic tTIS can improve motor symptoms of PD independently of medication. . Each participant underwent two separate 20-minute sessions of individualized 130 Hz STN-tTIS: one during medication "on" (defined as stable dopaminergic medication effect) and one during medication "off" (after ≥12 hours withdrawal of dopaminergic medications). The order of sessions was randomized with at least 7 days washout between sessions to avoid carryover effects. And MDS - UPDRS - III scales are assessed before and after each treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* MDS diagnosis of primary Parkinson's disease\n* Hoehn \\& Yahr stage \\< 3\n* Antiparkinsonian drugs remained unchanged in the past four weeks and dosage remained unchanged during the study\n\nExclusion Criteria:\n\n* Presence of neurological disorders that may affect the study (e.g., Traumatic brain injury)\n* History of antipsychotics, antidepressants, or dopamine modulators other than PD drugs\n* Metal devices in the head or heart (e.g., deep brain stimulators, pacemakers)\n* Unstable vital signs"}, 'identificationModule': {'nctId': 'NCT06980935', 'briefTitle': 'STN-tTIS Modulates Parkinson Motor Symptoms With and Without Medications', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Individualized 130 Hz Subthalamic Temporal Interference Stimulation Versus Medication for Motor Symptoms in Parkinson Disease', 'orgStudyIdInfo': {'id': '2025140A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Only use STN - tTIS therapy.', 'description': 'Patients in this group received two 20-minute individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere\'s STN during medication "off" (≥12 hours withdrawal) and were evaluated for the MDS - UPDRS - III before and after treatment.', 'interventionNames': ['Device: NervioX-2400']}, {'type': 'EXPERIMENTAL', 'label': 'STN - tTIS therapy is used in combination with medication.', 'description': 'Patients in this group received two 20-minute individualized 130 Hz STN-tTIS sessions targeting the more affected hemisphere\'s STN during medication "on" and were evaluated for the MDS - UPDRS - III before and after treatment.', 'interventionNames': ['Device: NervioX-2400']}], 'interventions': [{'name': 'NervioX-2400', 'type': 'DEVICE', 'description': "To design the individualized tTIS, each participant completed a T1-weighted anatomical magnetic resonance imaging (MRI) scan. The individual's structural brain MRI data were used to determine the tTIS montage and stimulation settings via computational modeling.", 'armGroupLabels': ['Only use STN - tTIS therapy.', 'STN - tTIS therapy is used in combination with medication.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}