Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-02-26 @ 4:14 PM
Study NCT ID:
NCT02887105
Status:
COMPLETED
Last Update Posted:
2016-09-08
First Post:
2016-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Memory and Emotion in Acute and Chronic Phases of Cerebrovascular Accident
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-07', 'studyFirstSubmitDate': '2016-08-24', 'studyFirstSubmitQcDate': '2016-08-29', 'lastUpdatePostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'State of anxiety evaluated with STAI-YA scale', 'timeFrame': 'up to 1 month (from CVA)'}, {'measure': 'State of anxiety evaluated with STAI-YA scale', 'timeFrame': '6 months (from CVA)'}, {'measure': 'Anxiety proneness evaluated with STAI-YB scale', 'timeFrame': 'up to 1 month (from CVA)'}, {'measure': 'Anxiety proneness evaluated with STAI-YB scale', 'timeFrame': '6 months (from CVA)'}, {'measure': 'Apprehension anxiety evaluated with Penn State Worry Questionnaire', 'timeFrame': 'up to 1 month (from CVA)'}, {'measure': 'Apprehension anxiety evaluated with Penn State Worry Questionnaire', 'timeFrame': '6 months (from CVA)'}, {'measure': 'Evaluation of working memory updating with N-back verbal and visuospatial task', 'timeFrame': 'up to 1 month (from CVA)'}, {'measure': 'Evaluation of working memory updating with N-back verbal and visuospatial task', 'timeFrame': '6 months (from CVA)'}, {'measure': 'Evaluation of working memory inhibition with Stimulus-response compatibility task', 'timeFrame': 'up to 1 month (from CVA)'}, {'measure': 'Evaluation of working memory inhibition with Stimulus-response compatibility task', 'timeFrame': '6 months (from CVA)'}, {'measure': 'Evaluation of working memory flexibility with Switching task', 'timeFrame': 'up to 1 month (from CVA)'}, {'measure': 'Evaluation of working memory flexibility with Switching task', 'timeFrame': '6 months (from CVA)'}, {'measure': 'Evaluation of verbal working memory with Wechsler memory scale', 'timeFrame': 'up to 1 month (from CVA)'}, {'measure': 'Evaluation of verbal working memory with Wechsler memory scale', 'timeFrame': '6 months (from CVA)'}, {'measure': 'Evaluation of visuospatial working memory with Wechsler memory scale', 'timeFrame': 'up to 1 month (from CVA)'}, {'measure': 'Evaluation of visuospatial working memory with Wechsler memory scale', 'timeFrame': '6 months (from CVA)'}, {'measure': 'Evaluation of visual episodic memory with Rey and Taylor figure test', 'timeFrame': '6 months (from CVA)'}, {'measure': 'Evaluation of verbal episodic memory with RL/RI 16 item test', 'timeFrame': '6 months (from CVA)'}], 'secondaryOutcomes': [{'measure': 'Hemispheric lateralization of lesions detected with MRI', 'timeFrame': 'up to 1 month from CVA'}, {'measure': 'Depression state evaluated with Back depression inventory', 'timeFrame': 'up to 1 month (from CVA)'}, {'measure': 'Depression state evaluated with Back depression inventory', 'timeFrame': '6 months (from CVA)'}, {'measure': 'Quality of life evaluated with SF-36 test', 'timeFrame': 'after 6 months from CVA'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cerebrovascular Accident']}, 'descriptionModule': {'briefSummary': 'The purpose is to determine the relationship between anxiety and cognitive performances in patients with acute and chronic phases of cerebrovascular accident (CVA). Data from neuropsychological assessment concerning cognitive processes (working and episodic memory) sensitive to different dimensions of anxiety will be analyzed.\n\nThe secondary purpose is to evaluate how some neurological (hemispherical lateralization of lesions), psychological (depression) and demographic (quality of life) variables can increase the effects of different dimensions of anxiety on cognitive processes, during the acute and/or chronic phase of CVA.', 'detailedDescription': 'Data will be collected during usual neuropsychological evaluation and cerebral imagery examination (NIHSS, Rankin scale) of patients in acute (0-1 month) and chronic (6 months) phases of CVA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized for a cerebrovascular accident', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute phase of carotid, vertebrobasilar or lacunar cerebrovascular accident with ischemic or hemorrhagic origin\n* Right-handed\n* Possible cooperation: understanding of French instructions\n* Normal or corrected vision\n* Normal or corrected hearing\n* Mini-mental state examination score higher than pathologic threshold according to age and sociocultural level of patient\n* Possible follow up of patient\n\nExclusion Criteria:\n\n* Hearing problems\n* Vision problems\n* Right hemiplegia or acute monoparesis of right upper limb\n* Hemispatial neglect\n* Apraxia\n* Psychiatric or neurological history possibly interfering with neuropsychological evaluation\n* Important defect of working memory or executive functions'}, 'identificationModule': {'nctId': 'NCT02887105', 'acronym': 'MEMOIRE ET EMO', 'briefTitle': 'Memory and Emotion in Acute and Chronic Phases of Cerebrovascular Accident', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Memory and Emotion in Acute and Chronic Phases of Cerebrovascular Accident', 'orgStudyIdInfo': {'id': 'PSS2012/MEMOIRE-DUCROCQ/MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with cerebrovascular accident', 'interventionNames': ['Other: Standard neuropsychological assessment', 'Other: Brain MRI']}], 'interventions': [{'name': 'Standard neuropsychological assessment', 'type': 'OTHER', 'armGroupLabels': ['Patients with cerebrovascular accident']}, {'name': 'Brain MRI', 'type': 'OTHER', 'armGroupLabels': ['Patients with cerebrovascular accident']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Metz', 'country': 'France', 'facility': 'Service de Neurologie - Hôpital Bon Secours - CHR de Metz-Thionville', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}, {'city': 'Nancy', 'country': 'France', 'facility': 'Service de Neurologie - Hôpital Central - CHU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Xavier DUCROCQ, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Neurologie - Unité Neurovasculaire - Hôpital Central Nancy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}