Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-28 @ 8:04 PM
Study NCT ID:
NCT06588920
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2024-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain Activity, Cognitive Function, and Walking Ability 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005684', 'term': 'Gait'}], 'ancestors': [{'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D016138', 'term': 'Walking'}, {'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2024-09-05', 'studyFirstSubmitQcDate': '2024-09-05', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait variability', 'timeFrame': '1 day', 'description': 'Using GAITRite system to measure the coefficient of variation (CV). The mean and standard deviation will be used to calculate the coefficient of variation (CV). CV = standard deviation / mean \\* 100%'}, {'measure': 'Gait speed', 'timeFrame': '1 day', 'description': 'Using GAITRite system to measure gait speed.'}, {'measure': 'Step length', 'timeFrame': '1 day', 'description': 'Using GAITRite system to measure step length'}, {'measure': 'Step width', 'timeFrame': '1 day', 'description': 'Using GAITRite system to measure step width.'}, {'measure': 'Single support time', 'timeFrame': '1 day', 'description': 'Using GAITRite system to measure single support time'}, {'measure': 'Double support time', 'timeFrame': '1 day', 'description': 'Using GAITRite system to measure double support time'}, {'measure': 'Frontal Assessment Battery', 'timeFrame': '1 day', 'description': 'The score ranged from 0 to 18. Higher scores show better executive function.'}, {'measure': 'Trail making test', 'timeFrame': '1 day', 'description': 'Trail making test contain part A and part B. Faster completing the test indicates better executive function.'}, {'measure': 'Stroop color and word test', 'timeFrame': '1 day', 'description': 'Record numbers of corrected color words which the subject responds within 45 sec.'}, {'measure': 'Digit span test', 'timeFrame': '1 day', 'description': 'Digit span test contain forward and backward part. Scores of forward digit span ranges from 0 to 16. Score of backward digit span ranges from 0 to 14. Higher scores indicate better executive function.'}, {'measure': 'Event-related potential - N2', 'timeFrame': '1 day', 'description': 'Measure event-related potential through electroencephalography under single-task and dual-task paradigm.'}, {'measure': 'Event-related potential - P300', 'timeFrame': '1 day', 'description': 'Measure event-related potential through electroencephalography under single-task and dual-task paradigm.'}, {'measure': 'Go/Nogo test', 'timeFrame': '1 day', 'description': 'Behavioral test during measuring electroencephalography.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Executive function', 'Gait', 'Electroencephalography'], 'conditions': ['Healthy Older Adults', 'Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'The dual-task automated walking performance in people with Parkinson\\'s disease (PD) is affected by their gait disturbances and impaired executive functions. Currently, the relationship between brain activity related to inhibitory control, executive functions, and dual-task walking performance in people with PD is not well understood. Therefore, this study aims to investigate the significance of different executive function domains on gait stability in healthy older adults and people with PD; whether brain activation related to inhibitory control is associated with gait stability in healthy older adults and people with PD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospital and community', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnoses of idiopathic Parkinson disease\n* Stable dopaminergic medicine ≥ 2 weeks\n* Able to walk 10 meters without aid\n* Mini-Mental Status Examination ≥ 24 points\n* No uncorrected visual or auditory disorders\n* Education at least junior high school\n* No other disease may affect balance\n\nExclusion Criteria:\n\n* Other medical diagnoses of neurological, musculoskeletal, or cardiopulmonary disorders\n* History of brain surgery (e.g. deep brain stimulation)'}, 'identificationModule': {'nctId': 'NCT06588920', 'briefTitle': "Brain Activity, Cognitive Function, and Walking Ability in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': "Brain Activity, Cognitive Function, and Walking Ability in People With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'NYCU113006AF1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Parkinson disease', 'description': 'People with Parkinson disease', 'interventionNames': ['Behavioral: Cognitive function, gait, and electroencephalogram']}, {'label': 'Healthy older adults', 'description': 'Healthy older adults', 'interventionNames': ['Behavioral: Cognitive function, gait, and electroencephalogram']}], 'interventions': [{'name': 'Cognitive function, gait, and electroencephalogram', 'type': 'BEHAVIORAL', 'description': 'Measurement of cognitive function, gait performance, and electroencephalogram', 'armGroupLabels': ['Healthy older adults', 'Parkinson disease']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yea-Ru Yang', 'role': 'CONTACT', 'email': 'yryang@nycu.edu.tw'}], 'facility': 'National Yang Ming Chiao Tung University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yea-Ru Yang, Professor', 'role': 'CONTACT', 'email': 'yryang@nycu.edu.tw', 'phone': '886-2-2826-7279'}], 'facility': 'National Yang Ming Chiao Tung University', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yea-Ru Yang, PhD', 'role': 'CONTACT', 'email': 'yryang@nycu.edu.tw', 'phone': '+886228267279'}]}, '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'}}}}