Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-01-05 @ 6:15 PM
Study NCT ID:
NCT00713050
Status:
TERMINATED
Last Update Posted:
2013-06-11
First Post:
2008-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Speech and Language Therapy After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D001037', 'term': 'Aphasia'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013064', 'term': 'Speech Disorders'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'whyStopped': 'Protocol expired; PI retired', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-10', 'studyFirstSubmitDate': '2008-07-09', 'studyFirstSubmitQcDate': '2008-07-09', 'lastUpdatePostDateStruct': {'date': '2013-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in scores on Western Aphasia Battery', 'timeFrame': 'Four months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'aphasia', 'imitation', 'mirror neuron'], 'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '27053642', 'type': 'DERIVED', 'citation': 'Duncan ES, Schmah T, Small SL. Performance Variability as a Predictor of Response to Aphasia Treatment. Neurorehabil Neural Repair. 2016 Oct;30(9):876-82. doi: 10.1177/1545968316642522. Epub 2016 Apr 6.'}]}, 'descriptionModule': {'briefSummary': 'Our overall goal is to advance the state of functional brain imaging in aphasia, and then to apply the method to an intensive, imitation-based treatment for non-fluent aphasia.', 'detailedDescription': 'Detailed information will follow in the next progress report.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Single ischemic infarction in the MCA territory involving the cerebral cortex (confirmed by CT or MRI)\n2. Aphasia\n3. Visual attention and language comprehension sufficient to perform imitation fMRI tasks\n4. Right handed (prior to stroke)\n\nExclusion Criteria:\n\nExclusions to the study are people with cardiac pacemakers, claustrophobia, neurosurgical clips, or cognitive impairments too severe to permit cooperation with cognitive tasks in an MRI scanner.'}, 'identificationModule': {'nctId': 'NCT00713050', 'briefTitle': 'Speech and Language Therapy After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Neurophysiological Measurement in Aphasia Treatment', 'orgStudyIdInfo': {'id': '13785A'}, 'secondaryIdInfos': [{'id': '5R01DC007488-05', 'link': 'https://reporter.nih.gov/quickSearch/5R01DC007488-05', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Computer-based Aphasia therapy', 'interventionNames': ['Behavioral: Imitate Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control Arm - Healthy subjects.', 'interventionNames': ['Behavioral: Imitate Therapy']}], 'interventions': [{'name': 'Imitate Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Imitate'], 'description': 'Imitation-based computer therapy', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Solodkin/Small Brain Circuits Laboratory', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'Steven Small, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}, {'name': 'Shirley Ryan AbilityLab', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}