Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-01-07 @ 8:39 AM
Study NCT ID:
NCT03277534
Status:
COMPLETED
Last Update Posted:
2017-09-11
First Post:
2017-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrical Stimulation Combined With Motor Training on EEG-EMG Coherence and Motor Function in Individuals With Stroke
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': 'D004558', 'term': 'Electric Stimulation'}], 'ancestors': [{'id': 'D010812', 'term': 'Physical Stimulation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-06', 'studyFirstSubmitDate': '2017-09-05', 'studyFirstSubmitQcDate': '2017-09-06', 'lastUpdatePostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Assessment for Upper Extremity', 'timeFrame': 'before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended', 'description': 'evaluate changes in upper extremity function of the stroke subjects'}, {'measure': 'EEG-EMG coherence', 'timeFrame': 'before intervention, four weeks after, at the end of the eight-week intervention and four weeks after the intervention period ended', 'description': 'evaluate changes in functional connectivity between motor cortex and active muscles'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['electrical stimulation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This study investigated whether electrical stimulation (ES) prior to a hand function training session for a total of eight weeks can better improve neuromuscular control and hand function in subacute stroke individuals and change electroencephalography-electromyography (EEG-EMG) coherence, as compared to the control (sham ES).', 'detailedDescription': 'Subjects were randomly assigned into ES and control groups. Both groups received 20-minute hand function training twice a week, and the ES group received 40-minute ES on the median nerve of the affected side before each training session. The control group received sham ES - electrodes were placed on the same location but no electric current was applied. EEG, EMG and Fugl-Meyer Assessment (FMA) were collected before, at the 4th week, at the end of 8th week, and 4 weeks after the end of intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. first-ever cerebral cortical region involved chronic stroke, onset over a month,\n2. able to perform active thumb flexion on the affected side with the scores of manual muscle test at least two points, and\n3. at stable medical condition for intervention\n\nExclusion Criteria:\n\n1. history of other neurological disorders,\n2. cognitive impairment (Mini-Mental State Examination score \\<24, MMSE),26\n3. unable to follow orders,\n4. contraindications of ES, and\n5. under 20 years old'}, 'identificationModule': {'nctId': 'NCT03277534', 'briefTitle': 'Electrical Stimulation Combined With Motor Training on EEG-EMG Coherence and Motor Function in Individuals With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': 'Effects of 8-week Sensory Electrical Stimulation Combined With Motor Training on EEG-EMG Coherence and Motor Function in Individuals With Stroke', 'orgStudyIdInfo': {'id': '104-2314-B-010-024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electrical stimulation', 'interventionNames': ['Other: Electrical stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'interventionNames': ['Other: Sham electrical stimulation']}], 'interventions': [{'name': 'Electrical stimulation', 'type': 'OTHER', 'description': 'sensory electrical stimulation was applied prior to upper limb functional training', 'armGroupLabels': ['Electrical stimulation']}, {'name': 'Sham electrical stimulation', 'type': 'OTHER', 'description': 'electrodes were placed on the same location as the Electrical stimulation condition, but no electric current was applied', 'armGroupLabels': ['Control']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Li-Wei Chou', 'investigatorAffiliation': 'National Yang Ming Chiao Tung University'}}}}