Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-03-05 @ 12:22 PM
Study NCT ID:
NCT05066659
Status:
UNKNOWN
Last Update Posted:
2021-10-04
First Post:
2021-09-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balance Performance and Corticomotor Inhibition in PD
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-09-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-23', 'studyFirstSubmitDate': '2021-09-23', 'studyFirstSubmitQcDate': '2021-09-23', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intracortical inhibition', 'timeFrame': '20 minutes', 'description': 'Short-interval intracortical inhibition assessed by transcranial magnetic stimulation'}, {'measure': 'Corticospinal inhibition', 'timeFrame': '20 minutes', 'description': 'Cortical silent period assessed by transcranial magnetic stimulation'}, {'measure': 'Static balance', 'timeFrame': '3 minutes', 'description': 'Sharpened Romberg test'}, {'measure': 'Dynamic balance', 'timeFrame': '5 minutes', 'description': 'Functional reach test'}, {'measure': 'Functional balance', 'timeFrame': '15 minutes', 'description': 'Mini-Balance Evaluation Systems Test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's disease; Transcranial magnetic stimulation; Motor cortex; Corticomotor inhibition; Balance performance"], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Postural instability is one of the motor features of Parkinson's disease (PD). Most patients will develop balance dysfunction, and they may get worse with disease progression. According to previous studies, people with PD had abnormal changes in corticomotor excitability, especially disinhibition in the primary motor cortex (M1). Some evidence had shown that the cortical function in the M1 is crucial for the pathophysiology of the underlying motor symptoms in PD. Furthermore, neurostimulation over the M1 could modulate the corticomotor excitability in individuals with PD, and then improve their motor and also balance performance. However, whether the impaired corticomotor inhibition relates to balance dysfunction in people with PD is still unknown. In this study, the purpose is to investigate the possible relationship between corticomotor inhibition and balance performance in individuals with PD. However, the postural position during TMS measurement may affect the corticomotor excitability. To further establish the above-mentioned relationship, the secondary purpose is to explore and confirm whether the postural position will influence the correlation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "people with Parkinson's disease", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the Hoehn and Yahr stage between 1 and 3\n* age 40 to 80 years\n* a stable treatment of anti-PD medications\n\nExclusion Criteria:\n\n* any contraindications of TMS\n* any injury histories or disorders affecting balance\n* any neurosurgery experience\n* neurologic conditions other than PD\n* the Mini-mental State Examination (MMSE) score \\< 24'}, 'identificationModule': {'nctId': 'NCT05066659', 'briefTitle': 'Balance Performance and Corticomotor Inhibition in PD', 'organization': {'class': 'OTHER', 'fullName': 'National Yang Ming Chiao Tung University'}, 'officialTitle': "Relationship Between Balance Performance and Corticomotor Inhibition in Individuals With Parkinsons' Disease", 'orgStudyIdInfo': {'id': 'YM110122F'}}, 'contactsLocationsModule': {'locations': [{'zip': '112', 'city': 'Taipei', 'country': 'Taiwan', 'contacts': [{'name': 'Yea-Ru Yang, PhD', 'role': 'CONTACT', 'email': 'yryang@nycu.edu.tw', 'phone': '886228267279'}], 'facility': 'Department of Physical Therapy and Assistive Technology, 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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, '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'}}}}