Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-01-13 @ 6:52 PM
Study NCT ID:
NCT01951612
Status:
UNKNOWN
Last Update Posted:
2016-07-20
First Post:
2013-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002546', 'term': 'Ischemic Attack, Transient'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'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': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2013-09-24', 'studyFirstSubmitQcDate': '2013-09-24', 'lastUpdatePostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in neuropsychological test performance at post-intervention', 'timeFrame': 'Baseline and post-intervention at 10 weeks', 'description': 'Performance will be assessed using standardized neuropsychological tests of processing speed, attention, executive functions, visuospatial abilities, and learning and memory. A composite measure of executive functioning derived from principal components analysis will be used as the primary outcome measure.'}, {'measure': 'Change from baseline in neuropsychological test performance at 2 month follow-up', 'timeFrame': 'Baseline and follow-up at 2 months', 'description': 'Performance will be assessed using standardized neuropsychological tests of processing speed, attention, executive functions, visuospatial abilities, and learning and memory. A composite measure of executive functioning derived from principal components analysis will be used as the primary outcome measure.'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in neuroimaging (fMRI/EEG) markers at post-intervention', 'timeFrame': 'Baseline and post-intervention at 10 weeks', 'description': 'Measurement of fMRI and EEG signal changes at post-intervention (10 weeks) will be used. Measures of brain activation and network function will be used as secondary outcome measures.'}, {'measure': 'Change from baseline in neuroimaging (fMRI/EEG) markers at 2 month follow-up', 'timeFrame': 'Baseline and follow-up at 2 months', 'description': 'Measurement of fMRI and EEG signal changes at follow-up (2 months) will be used. Measures of brain activation and network function will be used as secondary outcome measures.'}]}, 'conditionsModule': {'keywords': ['cognitive impairment', 'ischemic white matter disease', 'small vessel disease', 'transient ischemic attack', 'mild stroke', 'stroke risk'], 'conditions': ['Ischemic White Matter Disease', 'Transient Ischemic Attack', 'Mild Stroke', 'Stroke Risk']}, 'descriptionModule': {'briefSummary': 'Stroke is a leading cause of disability; most strokes (80%) are subcortical, with ischemic damage due to occlusion in penetrating arteries. Although ischemic white matter disease (iWMD) may lack gross clinical manifestation, it causes significant cognitive impairment, particularly on measures of executive function, attention, and memory. This impairment is attributable to diffuse damage affecting network connections.\n\nWhile there are many studies concerning rehabilitation of motor function and language in patients with large focal strokes, few studies have addressed attentional and executive functions. To our knowledge, there are no such studies on iWMD. In this study, patients will be randomized to a novel intervention for improving executive function and a control condition matched for therapist exposure. Patients will be assessed pre-intervention, post-intervention, and at long-term follow-up using a battery of behavioural and neuroimaging tasks. We predict that the novel intervention will be associated with improved executive function, as assessed behaviourally, and improved frontal network function, as assessed through neuroimaging markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with ischemic white matter disease or small vessel disease, who have experienced a transient ischemic attack, mild stroke, or are at risk of stroke\n* Fluent in English\n* Able to provide informed consent to all procedures\n* Sufficient motor and sensory functioning to complete all study components (with correction or assistance as required)\n\nExclusion Criteria:\n\n* Substance abuse\n* Other psychiatric condition (other than mood, personality, or behaviour change following onset/diagnosis of white matter disease or related condition mentioned above)\n* Other medical condition suspected to influence cognition'}, 'identificationModule': {'nctId': 'NCT01951612', 'briefTitle': 'Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Baycrest'}, 'officialTitle': 'Cognitive Changes and Rehabilitation in People With Transient Ischemic Attack, Stroke, or Stroke Risk Factors', 'orgStudyIdInfo': {'id': '08-53'}, 'secondaryIdInfos': [{'id': '232-2009', 'type': 'OTHER', 'domain': 'Sunnybrook Health Sciences Centre'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Executive Function Training Program', 'description': 'Participants in this group will receive the novel intervention training.', 'interventionNames': ['Behavioral: Executive Function Training Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Psychoeducational Training Program', 'description': 'Participants in this group will receive the control intervention training.', 'interventionNames': ['Behavioral: Psychoeducational Training Program']}], 'interventions': [{'name': 'Executive Function Training Program', 'type': 'BEHAVIORAL', 'description': 'Participants will take part in ten 2-hour sessions over 5 weeks.', 'armGroupLabels': ['Executive Function Training Program']}, {'name': 'Psychoeducational Training Program', 'type': 'BEHAVIORAL', 'description': 'Participants will take part in ten 2-hour sessions over 5 weeks.', 'armGroupLabels': ['Psychoeducational Training Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M6A 2E1', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Brian Levine, PhD', 'role': 'CONTACT', 'email': 'blevine@research.baycrest.org', 'phone': '416-785-2500', 'phoneExt': '3593'}, {'name': 'Nivethika Jeyakumar, BSc', 'role': 'CONTACT', 'email': 'njeyakumar@research.baycrest.org', 'phone': '416-785-2500', 'phoneExt': '3104'}, {'name': 'Brian Levine, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baycrest', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Brian Levine, PhD', 'role': 'CONTACT', 'email': 'blevine@research.baycrest.org', 'phone': '416-785-2500', 'phoneExt': '3593'}, {'name': 'Nivethika Jeyakumar, BSc', 'role': 'CONTACT', 'email': 'njeyakumar@research.baycrest.org', 'phone': '416-785-2500', 'phoneExt': '3104'}], 'overallOfficials': [{'name': 'Brian Levine, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rotman Research Institute, Baycrest'}, {'name': 'Gary Turner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}, {'name': 'Sandra Black, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baycrest', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Scientist', 'investigatorFullName': 'Brian Levine', 'investigatorAffiliation': 'Baycrest'}}}}