Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT02037451
Status:
UNKNOWN
Last Update Posted:
2014-01-16
First Post:
2014-01-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Auditory Cueing on Rhythmic Movement and Cortical Excitability in Patients With 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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-14', 'studyFirstSubmitDate': '2014-01-14', 'studyFirstSubmitQcDate': '2014-01-14', 'lastUpdatePostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Finger Tapping', 'timeFrame': 'Baseline,45-60 minutes.', 'description': 'Record pre-test and post-test change.'}, {'measure': 'Motor evoked potential', 'timeFrame': 'Baseline,45-60 minute', 'description': 'Use single-pulse TMS to assess Motor evoked potential change.'}, {'measure': 'Intracortical inhibition & Intracortical facilitation', 'timeFrame': 'Baseline,45-60 minutes', 'description': 'Use paired-pulse TMS to record pre-test and post-test change.'}, {'measure': 'Blood oxygen dependent level', 'timeFrame': 'Baseline, in experiment,45-60 minutes', 'description': 'Use Near-infrared spectroscopy to record pre-test, in experiment, and post-test change.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["Parkinson's disease", 'Auditory Cueing'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "Parkinson's disease (PD) is a progressive degenerative disease of central nervous systems deficit. The clinical symptoms of Parkinson's disease include the following motor tasks: difficult in initiating movement, performing rhythmic movement or serial movement, the ability of learning motor movement is also affected. The primary treatment for Parkinson's disease is medical treatment; surgery is used if in need. Rehabilitation such as physical therapy, which aims to improve patient's quality of life and functions, is a non-invasive treatment and value for PD patients. Auditory cue is a technique that widely applied on training patients with Parkinson's disease, and some researches revealed that auditory cueing could improve motor performance. However, the mechanism under this treatment technique is still unknown.\n\nThis study is to investigate the effect of auditory cueing on rhythmic finger movement in patients with Parkinson's disease. To investigate the mechanism under auditory cueing, neurophysiological data such as motor cortex excitability and blood flow in cortical cortex will be obtained by using Transcranial magnetic stimulation (TMS) and near infrared spectroscopy (NIRS)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Parkinson disease\n\nExclusion Criteria:\n\n* Clinical diagnosis of other neurological diseases\n* Dementia\n* Been diagnosed with any mental illness\n* History of seizures\n* Brain trauma\n* Body with a pacemaker or other electrical stimulator\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02037451', 'briefTitle': "The Effects of Auditory Cueing on Rhythmic Movement and Cortical Excitability in Patients With Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung University'}, 'orgStudyIdInfo': {'id': '102-3809A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention group', 'description': 'intervention group which receive auditory cueing while performing movement', 'interventionNames': ['Procedure: rhythmic auditory stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'control group which performing movement after listen to required movement rhythm.'}], 'interventions': [{'name': 'rhythmic auditory stimulation', 'type': 'PROCEDURE', 'description': 'Participants perform the finger tapping at the same time give rhythmic auditory stimulation ,and need to execute tapping with auditory stimulation.', 'armGroupLabels': ['intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333', 'city': 'Taoyuan District', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Ya-Ju Chang, PhD', 'role': 'CONTACT', 'email': 'yjchang@mail.cgu.edu.tw', 'phone': '88632118800', 'phoneExt': '5515'}], 'facility': 'Chang Gung University', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Profesor', 'investigatorFullName': 'Ya-Ju Chang', 'investigatorAffiliation': 'Chang Gung University'}}}}