Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-22 @ 10:15 AM
Study NCT ID:
NCT02397967
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2015-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reading Disability in Children With NF1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009456', 'term': 'Neurofibromatosis 1'}, {'id': 'D004410', 'term': 'Dyslexia'}], 'ancestors': [{'id': 'D017253', 'term': 'Neurofibromatoses'}, {'id': 'D009455', 'term': 'Neurofibroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D000067559', 'term': 'Specific Learning Disorder'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2015-03-13', 'studyFirstSubmitQcDate': '2015-03-24', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phonological deficits evaluated by the metaphonological capabilities including a subtraction test and phonemic Acronym test and memory capacity with phonological phonological memory test.', 'timeFrame': '24 hours', 'description': 'Evaluate whether there is a specificity of phonological deficits in children with NF1 compared with a population of children with the same age and same reading level, taking into account the intellectual level.'}], 'secondaryOutcomes': [{'measure': 'Visual-perceptual performance established from three tests: Test of Identical Forms (Thurstone), Judgment Test of orientation Lines (Benton) and global and partial deferral Tasks (S Valdois).', 'timeFrame': '24 hours', 'description': 'Studying the correlations between phonological deficits and visio-spatial and literacy skills.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NF1', 'children', 'reading disabilities'], 'conditions': ['Neurofibromatosis Type 1']}, 'referencesModule': {'references': [{'pmid': '33507832', 'type': 'DERIVED', 'citation': 'Biotteau M, Tournay E, Baudou E, Destarac S, Iannuzzi S, Faure-Marie N, Castelnau P, Schweitzer E, Rodriguez D, Kemlin I, Dorison N, Rivier F, Carneiro M, Preclaire E, Barbarot S, Lauwers-Cances V, Chaix Y. Reading Comprehension Impairment in Children With Neurofibromatosis Type 1 (NF1): The Need of Multimodal Assessment of Attention. J Child Neurol. 2021 Jul;36(8):625-634. doi: 10.1177/0883073820981270. Epub 2021 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'A national, multicenter, randomized, transverse clinical trial, estimating the existence of phonological deficits in children with NF1 children compared with control children without NF1 with the same reading level.', 'detailedDescription': 'To determine the phonological and visio -spatial performances at the NF1 children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age included between 8 and 12 years\n* Child presenting a type 1 neurofibromatosis according to 2 criteria in the following criteria list :\n\n * At least 6 café au lait spots\n * 2 or more neurofibromas or 1 plexiform neurofibroma\n * axillary or inguinal freckling\n * 1 optic nerf glioma\n * 2 or more Lisch nodules\n * 1 osseous lesion as sphenoid dysplasia or thinning of the long bone cortex with or without pseudoarthrosis\n * 1 A first degree relative (parent, sibling, or offspring) with NF1 by the above criteria\n* Membership in a national insurance\n* Consent of the child and the parents\n\nExclusion Criteria:\n\n* Mental retardation (QI T \\< 70)\n* Treated or untreated epilepsy\n* Visual deficit (visual Acuteness \\< 4/10\n* Presence of a symptomatic optic glioma\n* Presence of a brain tumor.'}, 'identificationModule': {'nctId': 'NCT02397967', 'briefTitle': 'Reading Disability in Children With NF1', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Neuropsychological Characterisation of Cognitive Deficits Involved in Reading Disability in Children With NF1', 'orgStudyIdInfo': {'id': '08 113 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Children NF1', 'description': 'Children diagnosed with NF1 according the NIH criteria Neuropsychological assessments', 'interventionNames': ['Other: Neuropsychological assessments']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Control group children without NF1 with the same reading level Neuropsychological assessments', 'interventionNames': ['Other: Neuropsychological assessments']}], 'interventions': [{'name': 'Neuropsychological assessments', 'type': 'OTHER', 'description': 'Neuropsychological assessments:\n\nIntelligence Quotient (WISC-IV)\n\nReading tests (reading accuracy, reading speed, reading comprehension and strategy):\n\nAlouette test, Lobrot test, Odedys test. Visio-spatial skill (JLO, Thurston, Corsi tests) Attention (CPT 2, CBCL) Receptive oral language (EVIP)', 'armGroupLabels': ['Children NF1', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69677', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital femme-mére-enfant, Hospices civils de lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Hôpital Gui de Chauliac', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44903', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU Hôtel-Dieu, Clinic of Dermatology', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP Hopital Armand Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '31073', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital des Enfants', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'Hopital Gatien de Clocheville', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Yves CHAIX, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}