Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-21 @ 10:11 PM
Study NCT ID:
NCT02819167
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2016-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain and Cognitive Reserve
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], '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': 'D020521', 'term': 'Stroke'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2016-06-28', 'studyFirstSubmitQcDate': '2016-06-29', 'lastUpdatePostDateStruct': {'date': '2017-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'evaluation of cognitive prognosis', 'timeFrame': 'one year post Ischemic stroke', 'description': 'measure will be performed with the Mattis dementia rating scale'}], 'secondaryOutcomes': [{'measure': 'Volume of leucoencephalopathy', 'timeFrame': 'one year post Ischemic stroke', 'description': 'measure will be performed with a MRI'}, {'measure': 'volume of hippocampic', 'timeFrame': 'one year post Ischemic stroke', 'description': 'measure will be performed with a MRI'}, {'measure': 'brain injury', 'timeFrame': 'one year post Ischemic stroke', 'description': 'measure will be performed with a MRI'}, {'measure': 'volume of ischemic stroke', 'timeFrame': 'one year post Ischemic stroke', 'description': 'measure will be performed with a MRI'}, {'measure': 'evaluation of cognitive reserve', 'timeFrame': 'one year post Ischemic stroke', 'description': 'measure will be performed with the Cognitive reserve index questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ischemic stroke', 'brain reserve', 'cognitive reserve', 'cognitive prognosis'], 'conditions': ['Brain Ischemia']}, 'descriptionModule': {'briefSummary': 'Ischemic strokes are one of the leading causes of handicap and death in elderly people in France.\n\nCognitive reserve (CR) is an active model, defined as a function of lifetime intellectual activities and other environmental factors that explain differential susceptibility to functional impairment in the presence of pathology or other neurological insult. CR is estimated using variables for cognitive activity: years of education, professional status, socioeconomic status… Furthermore, brain reverse (BR) is a passive and quantitative model that depend on brain size and other quantitative aspects of the brain that explain differential susceptibility to functional impairment in the presence of pathology.\n\nFirstly, volume and localization of ischemic strokes have a great impact on CR and BR due to brain injury. On the other hand, CR influences the severity and the expression of cognitive diseases.\n\nThe investigators realize a prospective study in order to assess the impact of CR and BR on cognitive prognosis after a right middle cerebral artery ischemic stroke in elderly patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥70 years old\n* right middle cerebral artery ischemic stroke\n* hospitalized in neurovascular unit of Pierre Wertheimer hospital between January 2015 to January 2016\n\nExclusion Criteria:\n\n* Contraindication for MRI\n* Hemorrhagic stroke\n* Aphasia'}, 'identificationModule': {'nctId': 'NCT02819167', 'acronym': 'BCN', 'briefTitle': 'Brain and Cognitive Reserve', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Neuro-anatomical Correlates on Volumetric MRI on the Impact of Brain Reserve and Cognitive Reserve on Ischemic Strokes in Elderly', 'orgStudyIdInfo': {'id': '69HCL16_0151'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'neurologic and neuropsychological evaluation', 'interventionNames': ['Other: neurologic and neuropsychological evaluation']}], 'interventions': [{'name': 'neurologic and neuropsychological evaluation', 'type': 'OTHER', 'description': 'cognitive prognosis, cognitive reserve, brain volume will be studied on patients with scale, questionnaire, magnetic resonance imaging', 'armGroupLabels': ['neurologic and neuropsychological evaluation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital des Charpennes', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Pierre Krolak Salmon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}