Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2025-12-27 @ 7:13 AM
Study NCT ID:
NCT04041661
Status:
UNKNOWN
Last Update Posted:
2019-08-06
First Post:
2019-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Concurrent Transcranial Direct Current Stimulation and Gait Training in Parkinson's Disease
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-02', 'studyFirstSubmitDate': '2019-07-31', 'studyFirstSubmitQcDate': '2019-07-31', 'lastUpdatePostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dual-task walking performance', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'To evaluate gait parameters while doing dual-task walking'}], 'secondaryOutcomes': [{'measure': 'Single walking performance', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'To evaluate gait parameters while doing single walking'}, {'measure': 'Trail-making test A & B', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'To evaluate executive function'}, {'measure': 'Stroop color and word test-Chinese version', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'To evaluate executive function'}, {'measure': 'Digit span test', 'timeFrame': 'Change from baseline at 4 weeks', 'description': 'To evaluate executive function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dual task performance', 'Executive function', 'Transcrainal direct current stimulation (tDCS)'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "To investigate the effect of concurrent transcranial direct current stimulation and gait training on gait performance when doing the cognitive dual-task in people with Parkinson's Disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with idiopathic PD\n* Hoehn and Yahr stages I-III\n* Mini Mental Status Examination (MMSE) score ≧ 24\n* Could walk 10m independently with or without gait aid\n\nExclusion Criteria:\n\n* Concurrent medication likely to affect mental performance\n* tDCS contraindication\n* Significant neurological, vestibular, visual disorders or psychiatric illness\n* Musculoskeletal or cardiopulmonary disease\n* Sensory system pathology'}, 'identificationModule': {'nctId': 'NCT04041661', 'briefTitle': "Concurrent Transcranial Direct Current Stimulation and Gait Training in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': "The Effect of Concurrent Transcranial Direct Current Stimulation and Gait Training on Gait Performance When Doing the Cognitive Dual-task in People With Parkinson's Disease", 'orgStudyIdInfo': {'id': '19MMHIS113e'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active tDCS plus gait training group', 'description': 'Participants in Active tDCS plus gait training group will execute Active tDCS on left dorsolateral prefrontal cortex which combined with treadmill, 12 times per week, least 4 weeks.', 'interventionNames': ['Other: Active tDCS plus gait training']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham tDCS plus gait training group', 'description': 'Participants in Sham tDCS plus gait training group will executeSham tDCS on left dorsolateral prefrontal cortex which combined with treadmill, 12 times per week, least 4 weeks.', 'interventionNames': ['Other: Sham tDCS plus gait training']}], 'interventions': [{'name': 'Active tDCS plus gait training', 'type': 'OTHER', 'description': 'Participants in experimental group will accept Active tDCS which combined with treadmill', 'armGroupLabels': ['Active tDCS plus gait training group']}, {'name': 'Sham tDCS plus gait training', 'type': 'OTHER', 'description': 'Participants in control group will accept Sham tDCS which combined with treadmill', 'armGroupLabels': ['Sham tDCS plus gait training group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yearu Yang, Ph.D', 'role': 'CONTACT', 'email': 'yryang@ym.edu.tw', 'phone': '+88628267279'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Yang Ming Chiao Tung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yea-Ru Yang', 'investigatorAffiliation': 'National Yang Ming Chiao Tung University'}}}}