Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-05 @ 5:33 PM
Study NCT ID:
NCT04638192
Status:
UNKNOWN
Last Update Posted:
2020-11-20
First Post:
2020-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Alternating Current Stimulation for Hand Function Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-17', 'studyFirstSubmitDate': '2020-11-17', 'studyFirstSubmitQcDate': '2020-11-17', 'lastUpdatePostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Magnetic resonance imaging', 'timeFrame': '3-month after the 10th session training', 'description': 'Structural and functional MRI'}], 'secondaryOutcomes': [{'measure': 'Action Research Arm Test (ARAT)', 'timeFrame': '3-month after the 10th session training', 'description': 'The ARAT has total 19 items, divided into 4 categories (grasp, grip, pinch, and gross arm movement). It ranges from 3 to 0 (best to worse).'}, {'measure': 'Fugl-Meyer Assessment (Upper Extremity)', 'timeFrame': '3-month after the 10th session training', 'description': 'The maximum score is 66, divided into 33 items in the form of a 3-point scale (0-2), 0 is cannot perform and 2 performs fully.'}, {'measure': 'Wolf Motor Function Test (WMFT)', 'timeFrame': '3-month after the 10th session training', 'description': 'The WMFT measures upper limb ability through timed and functional tasks. It has 17 items, ranging from 0 to 5 (worse to best).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'tACS has the potential to directly induce cortical alterations in the intrinsic neural oscillation at specific frequencies, and the brain could mirror the induced frequencies of the external source of oscillations from the stimulation. Hence, tACS with matching stimulation frequency could be an effective means of enhancing brain oscillatory activity to potentially induce synaptic plasticity for restoration of damaged brain functions. However from the existing studies of applying tACS over the M1 in healthy and diseased brains, there is a wide range of applied stimulation frequencies and varied neuromodulation effects on motor behavior or cortical excitability at different frequencies. In this proposal, subject-specific stimulation frequency and latency will be identified.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemiparesis subsequent to first-ever unilateral stroke for more than 6 months;\n* MCP and PIP finger joints can be extended to 180° passively;\n* Sufficient cognition to follow the experimental instructions\n\nExclusion Criteria:\n\n* Severe hand spasticity or hand deformity;\n* History of alcohol or drug abuse or epilepsy;\n* Bilateral brain infarcts;\n* Severe cognitive deficits;\n* Comprehensive aphasia;\n* Contraindications to tACS and MRI'}, 'identificationModule': {'nctId': 'NCT04638192', 'briefTitle': 'Transcranial Alternating Current Stimulation for Hand Function Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Design of Synchronized Pairing Peripheral Nerve Stimulation and Cortical Polarization to Promote Post-stroke Neuroplasticity for Hand Function Recovery', 'orgStudyIdInfo': {'id': '2017.663'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'subject-specific tACS', 'description': 'Constant current (1mA) will be applied for 20min at subject-specific stimulation frequency and latency', 'interventionNames': ['Device: tACS']}, {'type': 'EXPERIMENTAL', 'label': 'standard tACS', 'description': 'Constant current (1mA) will be applied for 20min at 20Hz with a fixed 25ms latency', 'interventionNames': ['Device: tACS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tACS', 'description': 'The stimulator will be shut down after 30s of stimulation. The patients will feel the initial itching sensation at the beginning in order to evaluate the placebo effect', 'interventionNames': ['Device: tACS']}], 'interventions': [{'name': 'tACS', 'type': 'DEVICE', 'description': 'A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.', 'armGroupLabels': ['Sham tACS', 'standard tACS', 'subject-specific tACS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shatin', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Raymond Tong, PhD', 'role': 'CONTACT'}], 'facility': 'Department of Biomedical Engineering, The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'centralContacts': [{'name': 'Raymond Tong, PhD', 'role': 'CONTACT', 'email': 'kytong@cuhk.edu.hk', 'phone': '+852 3943 8454'}], 'overallOfficials': [{'name': 'Raymond Tong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Biomedical Engineering, The Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman and Professor', 'investigatorFullName': 'Raymond KY Tong', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}