Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT06131320
Status:
COMPLETED
Last Update Posted:
2024-11-08
First Post:
2023-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brain Lesion and Visuospatial Impairment in CP Child
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-07', 'studyFirstSubmitDate': '2023-11-09', 'studyFirstSubmitQcDate': '2023-11-09', 'lastUpdatePostDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PVSE test results: total score and 8 sub-scores (length perception, size perception, angle comparison, midline localization, position perception, position selection, occipital score and parietal score.)', 'timeFrame': 'At the inclusion', 'description': 'Using normative values of PVSE test, we assess pathological measure inferior outlier limits and subnormal measure below the lower quartile limit'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cerebral Palsy, child, visuo-spatial disorder, brain lesion'], 'conditions': ['Children with Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'Children with cerebral palsy (CP) show varying degrees of motor impairment and movement disorders whose perceptive-visual contribution has yet to be established. The literature reports that children with CP have more frequent neuro-visual disorders. The link between the location and size of the brain lesion and neurovisual symptomatology has yet to be explored.\n\nIn this retrospective clinical data study, we will investigate in children with PC whether there is an anatomo-clinical correlation between visuo-spatial disorders is the brain injury of interest to the dorsal visual pathway. We will explore the volume of grey and white matter parietal involvement.\n\nTo test visuo-spatial disorders, we will use the PVSE (Visuo-Spatial Elementary Perception) test which does not require motor skills or language and is therefore suitable for children with a PC. This test will make it possible to better identify the deficit or deficits in order to adapt an early remediation. It could serve as a reference for comparing several pathologies/etiologies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children coming for out-patient consultation at the paediatric rehabilitation unit of the Hospices Civils de Lyon for a CP diagnosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 4 to 18 yo\n* With a CP diagnosis\n* With PVSE test completion during his/her regular follow-up\n* With a cerebral MRI scan during his/her regular follow-up\n\nExclusion Criteria:\n\n\\- With an incomplete PVSE test or whose interpretation was deemed unreliable by the rater'}, 'identificationModule': {'nctId': 'NCT06131320', 'acronym': 'EVSP-ANAT-CP', 'briefTitle': 'Brain Lesion and Visuospatial Impairment in CP Child', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Visuo-spatial Profile in Children with Cerebral Palsy Born At Term or Not and Anatomical Correlation', 'orgStudyIdInfo': {'id': '69HCL23_1053'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CP child', 'interventionNames': ['Diagnostic Test: PVSE Test', 'Other: Cerebral MRI']}, {'label': 'CP child with a PVSE test and a cerebral MRI performed during his/her follow-up', 'interventionNames': ['Diagnostic Test: PVSE Test', 'Other: Cerebral MRI']}], 'interventions': [{'name': 'PVSE Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Completion of the PVSE test', 'armGroupLabels': ['CP child', 'CP child with a PVSE test and a cerebral MRI performed during his/her follow-up']}, {'name': 'Cerebral MRI', 'type': 'OTHER', 'description': 'Cerebral MRI scan', 'armGroupLabels': ['CP child', 'CP child with a PVSE test and a cerebral MRI performed during his/her follow-up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Pediatric rehabilitation unit of the Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}