Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-29 @ 1:05 PM
Study NCT ID:
NCT05478057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-07-28
First Post:
2022-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D013064', 'term': 'Speech Disorders'}], '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'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}, {'id': 'D016503', 'term': 'Drug Delivery Systems'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-27', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-27', 'lastUpdatePostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of speech performance from baseline in experiment 1', 'timeFrame': 'Baseline ((1) before rTMS), (2) immediately after rTMS', 'description': '1. sustained phonation of /a/ for as long and steady as possible in one breath\n2. fast pa-/ta-/ka- repetition at least nine times in one breath\n3. reading a standardized paragraph composed of 80 words as clear and fast as possible'}, {'measure': 'Change of speech performance from baseline in experiment 2', 'timeFrame': 'Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS (3) 8 weeks later after 10 times of rTMS', 'description': '1. sustained phonation of /a/ for as long and steady as possible in one breath\n2. fast pa-/ta-/ka- repetition at least nine times in one breath\n3. reading a standardized paragraph composed of 80 words as clear and fast as possible'}, {'measure': 'Change of functional connectivity from baseline in experiment 2', 'timeFrame': 'Baseline ((1) before rTMS), (2) within 24 hours after 10 times of rTMS', 'description': 'use rs-fMRI to compare the functional connectivity between PD patients with and without speech disturbance and the changes of connectivity after rTMS over SMA'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['speech disturbance', 'transcranial magnetic stimulation'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'Speech disturbance is common in patients with Parkinson disease. Pharmacotherapy improves motor symptoms but has inconsistent effects on speech disturbance in PD patients. Transcranial magnetic stimulation (TMS) is a safe and non-invasive tool used for brain stimulation. Repetitive transcranial magnetic stimulation (rTMS) has positive effects on motor function of PD. Yet, its effect on speech disturbance seems to be inconclusive. Previous rTMS studies mainly focused on the primary motor cortex for PD speech disturbance. Nevertheless, we think supplementary motor area (SMA) may be a better target. Speech disturbance in PD may be associated with basal ganglia-thalamocortical motor circuits and SMA involves in the cortex part. In addition, neuroimaging studies showed that SMA were under-activation in PD patients. Therefore, we conduct this 3-year study including two experiments. The aim of the study is to determine if rTMS over SMA can improve the speech function of PD patients and change the functional connectivity of speech pathway in the brain. This will be the first study to investigate the effect of rTMS over SMA on speech.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Experiment 1\n\nInclusion Criteria:\n\n* right-handed healthy adult volunteers who understand and agree on the informed consent of the study\n\nExclusion Criteria:\n\n* pregnancy or possibility of pregnancy\n* history of seizure\n* family history of epilepsy\n* metals in any part of the body.\n\nExperiment 2\n\nInclusion Criteria:\n\n* PD patients with speech disturbance who understand and agree on the informed consent of the study. The speech item scored 2 or 3 in the unified Parkinson's disease rating scale (UPDRS) part III.\n\nExclusion Criteria:\n\n* dementia\n* the history of stroke, brain lesion, other central nervous system diseases\n* the contraindication of TMS which described above\n* any contraindication of MRI"}, 'identificationModule': {'nctId': 'NCT05478057', 'briefTitle': 'Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Supplementary Motor Area is a Potential Target for Speech Disturbance in Parkinson Disease', 'orgStudyIdInfo': {'id': '202102465A3A0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PD patients with speech disturbance treated with 10 Hz rTMS', 'interventionNames': ['Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system']}, {'type': 'SHAM_COMPARATOR', 'label': 'PD patients with speech disturbance treated with sham rTMS', 'interventionNames': ['Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system']}, {'type': 'EXPERIMENTAL', 'label': 'PD patients without speech disturbance treated with 10 Hz rTMS', 'interventionNames': ['Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system']}, {'type': 'SHAM_COMPARATOR', 'label': 'PD patients without speech disturbance with sham rTMS', 'interventionNames': ['Device: "MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system']}], 'interventions': [{'name': '"MAGSTIM" Repetitive transcranial magnetic stimulator (rTMS) system', 'type': 'DEVICE', 'description': 'we plan to recruit 60 patients with Parkinson disease, comprising 30 patients with speech disturbance and 30 age- and sex-match patients without speech disturbance. Each group of patients will be randomly divided into sham stimulation or rTMS. A total of 10 rTMS sessions will be applied in 2 weeks. The effect of rTMS will be evaluated via the changes of speech performance and functional connectivity which was analyzed from resting-state functional magnetic resonance imaging.', 'armGroupLabels': ['PD patients with speech disturbance treated with 10 Hz rTMS', 'PD patients with speech disturbance treated with sham rTMS', 'PD patients without speech disturbance treated with 10 Hz rTMS', 'PD patients without speech disturbance with sham rTMS']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}