Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-04-23 @ 7:55 AM
Study NCT ID:
NCT04920461
Status:
UNKNOWN
Last Update Posted:
2021-06-09
First Post:
2021-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-03', 'studyFirstSubmitDate': '2021-06-03', 'studyFirstSubmitQcDate': '2021-06-03', 'lastUpdatePostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of Neuro-Visual Disorder', 'timeFrame': 'Month 3', 'description': 'Presence of neuro-visual disorder will be confirmed by obtaining at least 2 pathological scores at following neuropsychological tests:\n\n* Rey \\& Taylor figures (score from 0 to 36, maximum)\n* Judgment of Line Orientation (score from 0 to 36, maximum)\n* Weschler Adult Intelligence Scale (final score is intelligence quotient, with an average score is fixed at 100)\n* Test of Attentional Performance\n* Visual Object and Space Perception Battery (eight tests each designed to assess a particular aspect of object or space perception, while minimising the involvement of other cognitive skills)\n* Visual agnosia assesment protocole (noted on 10 points)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Ischemic', 'Cerebellar Lesions']}, 'descriptionModule': {'briefSummary': 'This study aims at assessing the proportion of patients suffering from neuro-visual troubles (visual-spatial and/or visual-perceptual ), after cerebellar strokes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent form\n* Being able to pass initial neuropsychological tests within 10 days after stroke\n\nExclusion Criteria:\n\n* Previous central neural system/psychiatric/eye disease (including severe cranial trauma)\n* Chronic alcoholism\n* MRI contraindication.'}, 'identificationModule': {'nctId': 'NCT04920461', 'acronym': 'VISUO-CEREBRO', 'briefTitle': 'Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes', 'orgStudyIdInfo': {'id': 'P/2019/423'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Additional MRI sequences', 'interventionNames': ['Device: Additional MRI sequences', 'Other: Neuropsychological assessment']}], 'interventions': [{'name': 'Additional MRI sequences', 'type': 'DEVICE', 'description': 'Additional MRI sequences (3D T2 SPACE sequence, 4/5 minutes approximatively)', 'armGroupLabels': ['Additional MRI sequences']}, {'name': 'Neuropsychological assessment', 'type': 'OTHER', 'description': 'Neurovisual function assessed with neuropsychological tests', 'armGroupLabels': ['Additional MRI sequences']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'VOILLY Alice, MD', 'role': 'CONTACT', 'email': 'avoilly@chu-besancon.fr'}, {'name': 'Eloi MAGNIN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}], 'centralContacts': [{'name': 'Alice VOILLY, MD', 'role': 'CONTACT', 'email': 'avoilly@chu-besancon.fr', 'phone': '0033381668236'}], 'overallOfficials': [{'name': 'Eloi MAGNIN, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Besançon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}