NCT02397967

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

4.8 years

First QC Date

March 13, 2015

Last Update Submit

March 25, 2015

Conditions

Neurofibromatosis Type 1

Keywords

NF1childrenreading disabilities

Outcome Measures

Primary Outcomes (1)

  • Phonological deficits evaluated by the metaphonological capabilities including a subtraction test and phonemic Acronym test and memory capacity with phonological phonological memory test.

    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.

    24 hours

Secondary Outcomes (1)

  • 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).

    24 hours

Study Arms (2)

Children NF1

EXPERIMENTAL

Children diagnosed with NF1 according the NIH criteria Neuropsychological assessments

Other: Neuropsychological assessments

Control group

PLACEBO COMPARATOR

Control group children without NF1 with the same reading level Neuropsychological assessments

Other: Neuropsychological assessments

Interventions

Neuropsychological assessmentsOTHER

Neuropsychological assessments: Intelligence Quotient (WISC-IV) Reading tests (reading accuracy, reading speed, reading comprehension and strategy): Alouette test, Lobrot test, Odedys test. Visio-spatial skill (JLO, Thurston, Corsi tests) Attention (CPT 2, CBCL) Receptive oral language (EVIP)

Children NF1Control group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age included between 8 and 12 years
  • Child presenting a type 1 neurofibromatosis according to 2 criteria in the following criteria list :
  • At least 6 café au lait spots
  • or more neurofibromas or 1 plexiform neurofibroma
  • axillary or inguinal freckling
  • optic nerf glioma
  • or more Lisch nodules
  • osseous lesion as sphenoid dysplasia or thinning of the long bone cortex with or without pseudoarthrosis
  • A first degree relative (parent, sibling, or offspring) with NF1 by the above criteria
  • Membership in a national insurance
  • Consent of the child and the parents

You may not qualify if:

  • Mental retardation (QI T \< 70)
  • Treated or untreated epilepsy
  • Visual deficit (visual Acuteness \< 4/10
  • Presence of a symptomatic optic glioma
  • Presence of a brain tumor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hopital femme-mére-enfant, Hospices civils de lyon

Lyon, 69677, France

Location

Hôpital Gui de Chauliac

Montpellier, 34295, France

Location

CHU Hôtel-Dieu, Clinic of Dermatology

Nantes, 44903, France

Location

AP-HP Hopital Armand Trousseau

Paris, 75012, France

Location

Hôpital des Enfants

Toulouse, 31073, France

Location

Hopital Gatien de Clocheville

Tours, 37000, France

Location

Related Publications (1)

  • 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.

    PMID: 33507832DERIVED

MeSH Terms

Conditions

Neurofibromatosis 1Dyslexia

Condition Hierarchy (Ancestors)

NeurofibromatosesNeurofibromaNerve Sheath NeoplasmsNeoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplastic Syndromes, HereditaryNeurocutaneous SyndromesNervous System DiseasesHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Yves CHAIX, Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 25, 2015

Study Start

June 1, 2009

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

FR(6)