Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT04086160
Status:
UNKNOWN
Last Update Posted:
2023-03-01
First Post:
2019-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D020820', 'term': 'Dyskinesias'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental 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': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2019-07-27', 'studyFirstSubmitQcDate': '2019-09-09', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)', 'timeFrame': 'Within one week right before the 1st session of tDCS', 'description': 'normalized movement time (representing severity of parkinsonism). Unit: second/mm'}, {'measure': 'Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)', 'timeFrame': 'Within one week right after the 8th (last) session of tDCS', 'description': 'normalized movement time (representing severity of parkinsonism). Unit: second/mm'}, {'measure': 'Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)', 'timeFrame': 'Within one week right before the 1st session of tDCS', 'description': 'normalized number of movement units (representing severity of dyskinesia). Unit: units/mm'}, {'measure': 'Motion analysis by using an eight-camera motion capture system (VICON; Oxford Metrics Group, Oxford, UK)', 'timeFrame': 'Within one week right after the 8th (last) session of tDCS', 'description': 'normalized number of movement units (representing severity of dyskinesia). Unit: units/mm'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Schizophrenia', 'Psychosis', 'Parkinsonism', 'Dyskinesias']}, 'descriptionModule': {'briefSummary': 'The purposes of this research are to investigate (1) if schizophrenia patients and at-risk individuals present bradykinesia and dyskinesia and (2) if tDCS improves motor performance in schizophrenia patients and at-risk individuals. The first hypothesis is that both schizophrenia patients and at-risk individuals show bradykinesia and dyskinesia, and the motor symptoms are more severe in the former than the latter. The second hypothesis is that tDCS improves motor performance in schizophrenia patients and at-risk cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for schizophrenia patients:\n\n* a diagnosis of schizophrenia without other psychiatric diseases\n* having stable psychotic symptoms\n* a score of 22 or above in Hong Kong version Montreal Cognitive Assessment\n* having no neurological diseases and no medical conditions that affect motor performance\n\nNo Exclusion Criteria.\n\nInclusion Criteria for at-risk individuals:\n\n* a score of nine or above in the Chinese version of the 16-item Prodromal Questionnaire (CPQ-16)\n* a score of 22 or above in Hong Kong version Montreal Cognitive Assessment\n* having no diagnosis of psychiatric diseases\n* having no neurological diseases and no medical conditions that affect motor performance\n\nNo Exclusion Criteria.\n\nInclusion Criteria for healthy controls:\n\n* a score less than nine in CPQ-16\n* a score of 22 or above in Hong Kong version Montreal Cognitive Assessment\n* having no diagnosis of psychiatric diseases\n* having no neurological diseases and no medical conditions that affect motor performance.\n\nNo Exclusion Criteria.'}, 'identificationModule': {'nctId': 'NCT04086160', 'briefTitle': 'Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Effects of Transcranial Direct Current Stimulation (tDCS) on Motor Function in Schizophrenia Patients and Individuals at Risk for Psychotic Onset', 'orgStudyIdInfo': {'id': 'HSEARS20190518001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'schizophrenia- tDCS', 'interventionNames': ['Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)']}, {'type': 'SHAM_COMPARATOR', 'label': 'schizophrenia- sham', 'interventionNames': ['Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)']}, {'type': 'EXPERIMENTAL', 'label': 'at risk- tDCS', 'interventionNames': ['Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)']}, {'type': 'SHAM_COMPARATOR', 'label': 'at risk- sham', 'interventionNames': ['Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)']}, {'type': 'EXPERIMENTAL', 'label': 'healthy controls for schizophrenia- tDCS', 'interventionNames': ['Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)']}, {'type': 'SHAM_COMPARATOR', 'label': 'healthy controls for schizophrenia- sham', 'interventionNames': ['Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)']}, {'type': 'EXPERIMENTAL', 'label': 'healthy controls for at risk- tDCS', 'interventionNames': ['Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)']}, {'type': 'SHAM_COMPARATOR', 'label': 'healthy controls for at risk- sham', 'interventionNames': ['Device: Transcranial direct current stimulation device (Soterix Medical, New York, NY)']}], 'interventions': [{'name': 'Transcranial direct current stimulation device (Soterix Medical, New York, NY)', 'type': 'DEVICE', 'description': 'Transcranial direct current stimulation (tDCS) is a non-invasive intervention, which applies low-amplitude direct electric currents to the brain through scalp electrodes. The real (2mA) or sham tDCS intervention will be given for a total of eight sessions in four weeks with 20 minutes per session.', 'armGroupLabels': ['at risk- sham', 'at risk- tDCS', 'healthy controls for at risk- sham', 'healthy controls for at risk- tDCS', 'healthy controls for schizophrenia- sham', 'healthy controls for schizophrenia- tDCS', 'schizophrenia- sham', 'schizophrenia- tDCS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Shu-Mei Wang, PhD', 'role': 'CONTACT', 'email': 'shumei.wang@polyu.edu.hk', 'phone': '852-27664197'}], 'facility': 'Hong Kong Polytechnic University', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Shu-Mei Wang, PhD', 'role': 'CONTACT', 'email': 'shumei.wang@polyu.edu.hk', 'phone': '852-27664197'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr WANG Shumei', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr WANG Shumei', 'investigatorAffiliation': 'The Hong Kong Polytechnic University'}}}}