Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-17 @ 1:51 AM
Study NCT ID:
NCT04818268
Status:
TERMINATED
Last Update Posted:
2025-12-11
First Post:
2021-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sensory Memory in Speech Motor Learning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013060', 'term': 'Speech'}], 'ancestors': [{'id': 'D014705', 'term': 'Verbal Behavior'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000064', 'term': 'Acclimatization'}], 'ancestors': [{'id': 'D000222', 'term': 'Adaptation, Physiological'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D000220', 'term': 'Adaptation, Biological'}, {'id': 'D001686', 'term': 'Biological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-15', 'size': 266422, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2021-03-22T16:51', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'whyStopped': 'End of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2021-03-19', 'studyFirstSubmitQcDate': '2021-03-23', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech Motor Learning', 'timeFrame': 'Performance as measured at the end of learning (single day experiment)', 'description': 'Learning is assessed on a 0 to 100 scale as change in speech sounds (speech formant frequencies). A score of 100 corresponds to complete adaptation.'}, {'measure': 'Sensory Memory', 'timeFrame': 'Single day experiment', 'description': 'Sensory Memory is measured on a 0 to 100 scale. A score of 100 corresponds to perfect memory.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Speech', 'Consolidation']}, 'descriptionModule': {'briefSummary': 'The proposed studies focus on memory for speech movements and sounds and its relation to learning. Continuous theta-burst transcranial magnetic stimulation (cTBS) will be used to suppress activity in a region of pre-frontal cortex associated with somatic and auditory working memory (Brodmann area 46v) to test its involvement in learning.', 'detailedDescription': 'This study will assess the relationship between sensory working memory and speech motor adaptation using a between subjects design. Participants will be assigned to one of two groups. Each group will undergo both auditory and somatosensory working memory tests. This will be followed by adaptation to altered auditory feedback. Using a different group of subjects, cTBS will be used to disrupt neural activity in Brodmann area 46v in ventrolateral prefrontal cortex to test its involvement in adaptation. One set of tests will focus on the effects of cTBS on both auditory and somatosensory working memory. A second set of tests will focus on the effects of cTBS on speech motor adaptation to altered auditory feedback. Both working memory and adaptation are assessed on 0 to 100 scales.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* right handed adults\n* no known physical or neurological abnormalities\n\nExclusion Criteria:\n\n* patients with:\n* cardiac pacemaker\n* surgical clips or values on the heart\n* implants\n* metal or metallic fragments in any part of the body\n* pregnancy\n* claustrophobia\n* a personal or family history of epilepsy\n* currently taking antipsychotic drugs\n* currently taking antidepressant drugs\n* currently taking antianxiety drugs\n* history of concussion.'}, 'identificationModule': {'nctId': 'NCT04818268', 'briefTitle': 'Sensory Memory in Speech Motor Learning', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Role of Sensory Working Memory in Speech Motor Learning Aim 2', 'orgStudyIdInfo': {'id': '2000025475_a'}, 'secondaryIdInfos': [{'id': 'R01DC017439', 'link': 'https://reporter.nih.gov/quickSearch/R01DC017439', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adaptation to Altered Auditory Feedback', 'description': 'Adaptation to Altered Auditory Feedback', 'interventionNames': ['Behavioral: Adaptation']}, {'type': 'EXPERIMENTAL', 'label': 'Auditory Sensory Memory', 'description': 'Auditory Sensory Memory', 'interventionNames': ['Behavioral: Adaptation']}, {'type': 'EXPERIMENTAL', 'label': 'Somatosensory Sensory Memory', 'description': 'Somatosensory Sensory Memory', 'interventionNames': ['Behavioral: Adaptation']}, {'type': 'EXPERIMENTAL', 'label': 'Adaptation to Altered Auditory Feedback + cTBS to 46v', 'description': 'Adaptation to Altered Auditory Feedback + cTBS to 46v', 'interventionNames': ['Behavioral: Adaptation', 'Other: cTBS']}, {'type': 'EXPERIMENTAL', 'label': 'Sensory Memory + cTBS to 46v', 'description': 'Sensory Memory + cTBS to 46v', 'interventionNames': ['Behavioral: Adaptation', 'Other: cTBS']}], 'interventions': [{'name': 'Adaptation', 'type': 'BEHAVIORAL', 'description': 'Sensorimotor adaptation in speech', 'armGroupLabels': ['Adaptation to Altered Auditory Feedback', 'Adaptation to Altered Auditory Feedback + cTBS to 46v', 'Auditory Sensory Memory', 'Sensory Memory + cTBS to 46v', 'Somatosensory Sensory Memory']}, {'name': 'cTBS', 'type': 'OTHER', 'description': 'continuous theta-burst stimulation', 'armGroupLabels': ['Adaptation to Altered Auditory Feedback + cTBS to 46v', 'Sensory Memory + cTBS to 46v']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3A1G1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'David Ostry', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haskins Laboratories'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}