Neurofibromatosis Type 1NCT02397967
Reading Disability in Children With NF1
A study testing Neuropsychological assessments in people with Neurofibromatosis Type 1, run by University Hospital, Toulouse at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurofibromatosis Type 1
- What is being tested?
- Neuropsychological assessments
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 181 participants
- Where
- 6 sitesFrance
- Study dates
- Jun 2009to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
- 2 or more neurofibromas or 1 plexiform neurofibroma
- axillary or inguinal freckling
- 1 optic nerf glioma
Show all 11Show fewer
- 2 or more Lisch nodules
- 1 osseous lesion as sphenoid dysplasia or thinning of the long bone cortex with or without pseudoarthrosis
- 1 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hopital femme-mére-enfant, Hospices civils de lyon
Lyon, 69677
Hôpital Gui de Chauliac
Montpellier, 34295
CHU Hôtel-Dieu, Clinic of Dermatology
Nantes, 44903
AP-HP Hopital Armand Trousseau
Paris, 75012
Hôpital des Enfants
Toulouse, 31073
Hopital Gatien de Clocheville
Tours, 37000
About this study
Official title: Neuropsychological Characterisation of Cognitive Deficits Involved in Reading Disability in Children With NF1
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.
Read the detailed description
To determine the phonological and visio -spatial performances at the NF1 children.
- Conditions
- Neurofibromatosis Type 1
- Being tested
- Neuropsychological assessments
- Keywords
- NF1, children, reading disabilities
- Medical subject headings
- Neurofibromatosis 1, Dyslexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Children NF1 | Experimental | Children diagnosed with NF1 according the NIH criteria Neuropsychological assessments Receives: Other: Neuropsychological assessments |
| Control group | Placebo comparator | Control group children without NF1 with the same reading level Neuropsychological assessments Receives: Other: Neuropsychological assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Studying the correlations between phonological deficits and visio-spatial and literacy skills.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startJun 2009
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurofibromatosis Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 181 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves CHAIX, Professor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397967
- Sponsor's protocol ID
- 08 113 01
- Status last verified
- Mar 2015
- First submitted
- 13 Mar 2015
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33507832
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychological Characterisation of Cognitive Deficits Involved in Reading Disability in Children With NF1
- ClinicalTrials.gov ID
- NCT02397967
- Acronym / sponsor ID
- 08 113 01
- Conditions
- Neurofibromatosis Type 1
- Keywords
- NF1, children, reading disabilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 181 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To determine the phonological and visio -spatial performances at the NF1 children.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children NF1 | Experimental | Other: Neuropsychological assessmentsChildren diagnosed with NF1 according the NIH criteria Neuropsychological assessments |
| Control group | Placebo comparator | Other: Neuropsychological assessmentsControl group children without NF1 with the same reading level Neuropsychological assessments |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Age included between 8 and 12 years
- Child presenting a type 1 neurofibromatosis according to 2 criteria in the following criteria list :
- Membership in a national insurance
- Consent of the child and the parents
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological assessmentsNeuropsychological 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) | Other | Children NF1, Control group |
Primary outcome
Phonological deficits evaluated by the metaphonological capabilities including a subtraction test and phonemic Acronym test and memory capacity with phonological phonological memory test.
Time frame: 24 hours
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.
1 secondary outcome
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).
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2015.
- Derived from this study: PubMed 33507832Biotteau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves CHAIX, Professor principal investigator
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological assessments in people with Neurofibromatosis Type 1, run by University Hospital, Toulouse at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phonological deficits evaluated by the metaphonological capabilities including a subtraction test and phonemic Acronym test and memory capacity with phonological phonological memory test. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02397967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2015.