Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-01-01 @ 2:03 PM
Study NCT ID:
NCT02422732
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2015-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional Imaging and Reading Deficit 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005820', 'term': 'Genetic Testing'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-18', 'studyFirstSubmitDate': '2015-03-27', 'studyFirstSubmitQcDate': '2015-04-16', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of children performing in full the protocol functional MRI', 'timeFrame': 'day 1', 'description': 'Study the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities.'}], 'secondaryOutcomes': [{'measure': 'blood flow in milliliters per minute', 'timeFrame': 'day 1', 'description': 'Comparison of brain activations involved in phonological and visuo-spatial processing in 2 groups in children with NF1.\n\n1 group with reading disability and 1 group without reading disability Search for a link between the presence of a large deletion of the gene and learning disorders.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NF1', 'Children', 'Reading disability', 'Morphological and functional MRI', 'Genetic analysis'], 'conditions': ['Neurofibromatosis Type 1']}, 'descriptionModule': {'briefSummary': 'A monocenter pilot study on the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities.', 'detailedDescription': 'The principal aim of the study is to highlight the activation of brain area involved phonological and visuo-spatial processing in children with NF1 with or without reading disabilities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, '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 pseudarthrosis\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': 'NCT02422732', 'briefTitle': 'Functional Imaging and Reading Deficit in Children With NF1', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Functional Magnetic Resonance Imaging and Reading Deficit in Children With NF1 Children', 'orgStudyIdInfo': {'id': '08 154 02'}, 'secondaryIdInfos': [{'id': '2008-A01493-52', 'type': 'REGISTRY', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Children with reading disability', 'description': 'Children with NF1, with reading disability if their performances on reading assessment (Alouette Test) present a delay of at least 18 months, will have Neuropsychological assessments, morphological and functional MRI (fMRI) and genetic analysis', 'interventionNames': ['Other: Neuropsychological assessments', 'Radiation: morphological and functional MRI (fMRI)', 'Genetic: genetic analysis']}, {'type': 'OTHER', 'label': 'Children without reading disability', 'description': 'Children with NF1, without reading disability if their performances on reading assessment (Alouette Test) present a less than 18-month delay, will have Neuropsychological assessments, morphological and functional MRI (fMRI) and genetic analysis.', 'interventionNames': ['Other: Neuropsychological assessments', 'Radiation: morphological and functional MRI (fMRI)', 'Genetic: genetic analysis']}], 'interventions': [{'name': 'Neuropsychological assessments', 'type': 'OTHER', 'description': 'IQ (WISC-IV)\n\nReading tests (reading accuracy, reading speed, reading comprehension and strategy):\n\nAlouette, Lobrot, Odedys tests. Visuo-spatial skill (JLO, Thurston, CORSI tests) Attention (CPT 2, CBCL) Receptive oral language (EVIP)', 'armGroupLabels': ['Children with reading disability', 'Children without reading disability']}, {'name': 'morphological and functional MRI (fMRI)', 'type': 'RADIATION', 'description': 'The fMRI will consider on the acquisition of a 3D anatomical sequence in T1 high resolution in axial slices of 1mm with an acquisition time of 10 min and a T2 sequence and a "Flair" to allow UBO location.', 'armGroupLabels': ['Children with reading disability', 'Children without reading disability']}, {'name': 'genetic analysis', 'type': 'GENETIC', 'description': 'Blood collection in 3 tubes (2 PAXgen® and 1 EDTA) and analysis to study the NF1 gene deletion.', 'armGroupLabels': ['Children with reading disability', 'Children without reading disability']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Yves Chaix, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}