Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-01-06 @ 10:02 PM
Study NCT ID:
NCT05268159
Status:
COMPLETED
Last Update Posted:
2022-05-18
First Post:
2022-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Disconnection and Unilateral Spatial Neglect
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}], 'ancestors': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2022-02-24', 'studyFirstSubmitQcDate': '2022-03-04', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Assessment of peripersonal Unilateral Neglect with the BEN (Batterie d'évaluation de la negligence, Battery of tests for the quantitative assessment of unilateral neglect)", 'timeFrame': 'One assessment, during the subacute phase after stroke (3 weeks to 6 months)'}], 'secondaryOutcomes': [{'measure': 'Assessment of personal Unilateral Spatial Neglect with the Fluff Test', 'timeFrame': 'One assessment, during the subacute phase after stroke (3 weeks to 6 months)'}, {'measure': 'Assessment of personal Unilateral Spatial Neglect with the Comb and Razor Test', 'timeFrame': 'One assessment, during the subacute phase after stroke (3 weeks to 6 months)'}, {'measure': 'Assessment of Attention with the Test of Attentional Performance', 'timeFrame': 'One assessment, during the subacute phase after stroke (3 weeks to 6 months)'}, {'measure': 'Assessment of Executive Functions with the Stroop Test', 'timeFrame': 'One assessment, during the subacute phase after stroke (3 weeks to 6 months)'}, {'measure': 'Assessment of Executive Functions with the Trail Making Test', 'timeFrame': 'One assessment, during the subacute phase after stroke (3 weeks to 6 months)'}, {'measure': 'Assessment of Executive Function with Verbal and Categorial Fluency test', 'timeFrame': 'One assessment, during the subacute phase after stroke (3 weeks to 6 months)'}, {'measure': 'Assessment of Executive Functions with the test of commissions', 'timeFrame': 'One assessment, during the subacute phase after stroke (3 weeks to 6 months)'}, {'measure': 'Assessment of verbal Memory with the verbal span task', 'timeFrame': 'One assessment, during the subacute phase after stroke (3 weeks to 6 months)'}, {'measure': 'Assessment of verbal Memory with the Grober and Buschke Task', 'timeFrame': 'One assessment, during the subacute phase after stroke (3 weeks to 6 months)'}, {'measure': 'Assessment of visual Memory with the Doors test', 'timeFrame': 'One assessment, during the subacute phase after stroke (3 weeks to 6 months)'}, {'measure': 'Assessment of visual Memory with the Rey figure test', 'timeFrame': 'One assessment, during the subacute phase after stroke (3 weeks to 6 months)'}, {'measure': 'Identification of brain lesions by Anatomical MRI (T1, FLAIR, T2*, Diffusion)', 'timeFrame': 'up to 6 months'}, {'measure': 'Postural assessment with the PASS', 'timeFrame': '1 month after stroke'}, {'measure': 'Postural assessment with the PASS', 'timeFrame': '3 months after stroke'}, {'measure': 'Gait assessment (Lindmark score)', 'timeFrame': '1 month after stroke'}, {'measure': 'Gait assessment (Lindmark score)', 'timeFrame': '3 months after stroke'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Unilateral spatial neglect', 'MRI', 'Disconnectome,', 'Cognition'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Retrospective cohort study of consecutive patients investigated in a neurorehabilitation ward after a first hemispheric stroke. Unilateral spatial Neglect (USN) and other cognitive impairments (including attention, executive functions, memory) have been assessed in routine care at the subacute phase (\\<6 months). MRI scans have also been done in routine care.\n\nThe study aims at linking lesion characteristics, disconnections induced and expression of the different modalities of USN'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients admitted in neurorehabilitation ward after first hemispheric stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First hemispheric adult stroke patient\n* Non-opposed to inclusion\n* Confirmed by MRI\n* Assessment of cognitive functions during the subacute phase (3 weeks to 6 months after stroke onset\n\nExclusion Criteria:\n\n* History of previous stroke or neurological disorders\n* Inability to perform cognitive assessment due to severe comprehension, cognitive or psychiatric disorder\n* Uncorrected severe loss of visual acuity\n* Contra-indications to MRI'}, 'identificationModule': {'nctId': 'NCT05268159', 'acronym': 'DISCONEGLECT', 'briefTitle': 'Disconnection and Unilateral Spatial Neglect', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Neural Basis of Unilateral Spatial Neglect After Stroke: a Retrospective Disconnectome Based Study', 'orgStudyIdInfo': {'id': 'HLJ_2022_02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stroke patients', 'description': 'Stroke patients admitted to the Lille Neurological rehabilitation unit after a first-ever hemispheric stroke, assessed at the subacute phase (\\< 6months)', 'interventionNames': ['Other: Cognitive assessment']}], 'interventions': [{'name': 'Cognitive assessment', 'type': 'OTHER', 'description': 'Assessment of unilateral spatial neglect, attention, executive functions and memory', 'armGroupLabels': ['Stroke patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Hop Swynghedauw', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Etienne Allart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}