Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-01 @ 1:31 AM
Study NCT ID:
NCT04286308
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2020-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cortical-Basal Ganglia Speech Networks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020329', 'term': 'Essential Tremor'}, {'id': 'D004421', 'term': 'Dystonia'}], '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': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2020-01-08', 'studyFirstSubmitQcDate': '2020-02-25', 'lastUpdatePostDateStruct': {'date': '2024-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of subjects providing the interpretable speech related electrophysiological data collection.', 'timeFrame': 'Duration of single DBS surgery', 'description': 'The number of subjects providing the interpretable speech related electrophysiological data during DBS surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease', 'Essential Tremor', 'Dystonia']}, 'descriptionModule': {'briefSummary': 'In this research study the researchers want to learn more about brain activity related to speech perception and production.', 'detailedDescription': "Speech production is disrupted in a number of neurological diseases that involve the basal ganglia, including Parkinson's disease (PD) and dystonia. The investigators will use a novel experimental approach and combination of analytic techniques to elucidate the contribution of neural activity in cortical-basal ganglia circuits to the hierarchical control of speech production, in subjects undergoing deep brain stimulation surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects scheduled for DBS implantation, as determined by the clinical multidisciplinary movement disorders board with definitive diagnosis of Parkinson's disease, essential tremor or dystonia.\n2. Subjects able to provide informed consent and comply with task instructions.\n3. Subjects 18-85 years old\n\nExclusion Criteria:\n\n1. Subjects with reported hearing loss.\n2. Non-English-speaking subjects"}, 'identificationModule': {'nctId': 'NCT04286308', 'briefTitle': 'Cortical-Basal Ganglia Speech Networks', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Cortical-Basal Ganglia Speech Networks', 'orgStudyIdInfo': {'id': '2019P003841'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brain signal data collection', 'description': 'Brain signal data collection at the time of deep brain stimulation (DBS) surgery.', 'interventionNames': ['Other: electrophysiological data collection']}], 'interventions': [{'name': 'electrophysiological data collection', 'type': 'OTHER', 'description': 'Electrophysiological data collection at the time of DBS surgery.', 'armGroupLabels': ['Brain signal data collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Robert M Richardson, MD PhD', 'role': 'CONTACT', 'email': 'mark.richardson@mgh.harvard.edu', 'phone': '617-726-8849'}, {'name': 'Erin Donahue, PhD', 'role': 'CONTACT', 'email': 'ekdonahue@mgh.harvard.edu'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Mark Richardson, MD, PhD', 'role': 'CONTACT', 'email': 'mark.richardson@mgh.harvard.edu', 'phone': '617-726-8849'}, {'name': 'Erin Donahue, PhD', 'role': 'CONTACT', 'email': 'ekdonahue@mgh.harvard.edu'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Functional Neurosurgery', 'investigatorFullName': 'Robert Mark Richardson', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}