Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-28 @ 7:14 PM
Study NCT ID:
NCT04903457
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2021-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of tDCS on Motor Learning and Neural Network in Stroke Patients
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2021-05-23', 'studyFirstSubmitQcDate': '2021-05-25', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Resting-state functional MRI', 'timeFrame': 'Baseline (Before stimulation sessions)', 'description': 'Before intervention, MRI is acquired to extract brain characteristics of stroke patients.'}, {'measure': 'Changes in cortical activity using fNIRS signals.', 'timeFrame': 'Baseline (Before stimulation sessions)', 'description': 'Before intervention, fNIRS image is acquired to extract cortical activation of stroke patients.'}], 'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment', 'timeFrame': 'Baseline, immediately after five brain stimulation sessions', 'description': 'The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured.'}], 'secondaryOutcomes': [{'measure': 'Changes in cortical activity using fNIRS signals during brain stimulation', 'timeFrame': 'Baseline, during, immediately after five brain stimulation sessions', 'description': 'Cortical activities before, during and after brain stimulation sessions are compared.'}, {'measure': 'Changes in motor evoked potential', 'timeFrame': 'Baseline, immediately after five brain stimulation sessions', 'description': 'Resting motor threshold (rMT) and amplitude of motor evoked potential in first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response.'}, {'measure': '9-hole pegboard test', 'timeFrame': 'Baseline, immediately after five brain stimulation sessions', 'description': 'The test is a standardized, quantitative assessment used to measure finger dexterity of a patient.'}, {'measure': 'Grip & Tip pinch strength test', 'timeFrame': 'Baseline, immediately after five brain stimulation sessions', 'description': 'The test is to measure the maximum isometric strength of hand, forearm, and finger muscles.'}, {'measure': 'Box & Block test', 'timeFrame': 'Baseline, immediately after five brain stimulation sessions', 'description': 'The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device.'}, {'measure': 'Sequential Finger tapping test', 'timeFrame': 'Baseline, immediately after five brain stimulation sessions', 'description': 'Response time is measured during sequential finger tapping task.'}, {'measure': 'Jebsen-Taylor hand function test', 'timeFrame': 'Baseline, immediately after five brain stimulation sessions', 'description': 'This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation on motor learning to stroke patients compared to sham stimulation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral stroke including basal ganglia lesion patients\n* Chronic patients over 6 months after onset\n* Patients with the movement of fingers\n\nExclusion Criteria:\n\n* History of psychiatric disease\n* Significant other neurological diseases except for stroke\n* Difficult to perform this experiment\n* Patients who are deemed difficult to participate in this research by the investigator\n* Patients with metal implants and medical devices\n* History of epilepsy\n* Pregnancy\n* Skin defect at the site of electrode attachment'}, 'identificationModule': {'nctId': 'NCT04903457', 'briefTitle': 'The Effect of tDCS on Motor Learning and Neural Network in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Investigation of Compensational Mechanism and Effect of Transcranial Direct Stimulation on Motor Learning Through Neural Network Analysis in Stroke Patients', 'orgStudyIdInfo': {'id': '2021-04-075'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Real stimulation before motor learning training', 'description': 'Patients receive five sessions of tDCS stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system immediately before sequential finger tapping task.', 'interventionNames': ['Device: Transcranial Direct Current Stimulation', 'Behavioral: Motor learning']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sham stimulation before motor learning training', 'description': 'Patients receive five sessions of sham stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system immediately before sequential finger tapping task.', 'interventionNames': ['Behavioral: Motor learning']}], 'interventions': [{'name': 'Transcranial Direct Current Stimulation', 'type': 'DEVICE', 'description': 'Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.', 'armGroupLabels': ['Real stimulation before motor learning training']}, {'name': 'Motor learning', 'type': 'BEHAVIORAL', 'description': 'Sequential finger tapping task training is applied to stroke patients.', 'armGroupLabels': ['Real stimulation before motor learning training', 'Sham stimulation before motor learning training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06351', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Yun-Hee Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}