Neurofibromatosis Type 1NCT02422732
Functional Imaging and Reading Deficit in Children With NF1
A study testing Neuropsychological assessments, morphological and functional MRI (fMRI) and genetic analysis in people with Neurofibromatosis Type 1, run by University Hospital, Toulouse at 1 site in France.
Trial summary
A monocenter pilot study on the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Neurofibromatosis Type 1
- What is being tested?
- Neuropsychological assessments, morphological and functional MRI (fMRI) and genetic analysis
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2009to Apr 2015
- 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
- No healthy volunteers
- 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 pseudarthrosis
- 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
1 site in 1 country.
About this study
Official title: Functional Magnetic Resonance Imaging and Reading Deficit in Children With NF1 Children
A monocenter pilot study on the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities.
Read the detailed description
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.
- Conditions
- Neurofibromatosis Type 1
- Being tested
- Neuropsychological assessments, morphological and functional MRI (fMRI), genetic analysis
- Keywords
- NF1, Children, Reading disability, Morphological and functional MRI, Genetic analysis
- 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
IQ (WISC-IV)
Reading tests (reading accuracy, reading speed, reading comprehension and strategy):
Alouette, Lobrot, Odedys tests. Visuo-spatial skill (JLO, Thurston, CORSI tests) Attention (CPT 2, CBCL) Receptive oral language (EVIP)
morphological and functional MRI (fMRI)Radiation
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.
genetic analysisGenetic
Blood collection in 3 tubes (2 PAXgen® and 1 EDTA) and analysis to study the NF1 gene deletion.
| Study group | Role | What they receive |
|---|---|---|
| Children with reading disability | Other | 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 Receives: Other: Neuropsychological assessments; Radiation: morphological and functional MRI (fMRI); Genetic: genetic analysis |
| Children without reading disability | Other | 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. Receives: Other: Neuropsychological assessments; Radiation: morphological and functional MRI (fMRI); Genetic: genetic analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children performing in full the protocol functional MRI
Study the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities.
Measured: day 1
Secondary outcomes (1)
blood flow in milliliters per minute
Comparison of brain activations involved in phonological and visuo-spatial processing in 2 groups in children with NF1.
1 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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startMar 2009
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Chaix, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422732
- Sponsor's protocol ID
- 08 154 02
- Other IDs
- 2008-A01493-52
- Status last verified
- Aug 2015
- First submitted
- 27 Mar 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Magnetic Resonance Imaging and Reading Deficit in Children With NF1 Children
- ClinicalTrials.gov ID
- NCT02422732
- Acronym / sponsor ID
- 08 154 02
- Conditions
- Neurofibromatosis Type 1
- Keywords
- NF1, Children, Reading disability, Morphological and functional MRI, Genetic analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 21 Apr 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 monocenter pilot study on the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with reading disability | Other | Other: Neuropsychological assessments, Radiation: morphological and functional MRI (fMRI), Genetic: genetic analysisChildren 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 |
| Children without reading disability | Other | Other: Neuropsychological assessments, Radiation: morphological and functional MRI (fMRI), Genetic: genetic analysisChildren 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not 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 assessmentsIQ (WISC-IV) Reading tests (reading accuracy, reading speed, reading comprehension and strategy): Alouette, Lobrot, Odedys tests. Visuo-spatial skill (JLO, Thurston, CORSI tests) Attention (CPT 2, CBCL) Receptive oral language (EVIP) | Other | Children with reading disability, Children without reading disability |
| morphological and functional MRI (fMRI)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. | Radiation | Children with reading disability, Children without reading disability |
| genetic analysisBlood collection in 3 tubes (2 PAXgen® and 1 EDTA) and analysis to study the NF1 gene deletion. | Genetic | Children with reading disability, Children without reading disability |
Primary outcome
Percentage of children performing in full the protocol functional MRI
Time frame: day 1
Study the acceptability and feasibility of a functional MRI protocol in children with NF1 with or without reading disabilities.
1 secondary outcome
blood flow in milliliters per minute
Time frame: day 1
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 19 Aug 2015.
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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, MD PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological assessments, morphological and functional MRI (fMRI) and genetic analysis in people with Neurofibromatosis Type 1, run by University Hospital, Toulouse at 1 site 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Percentage of children performing in full the protocol functional MRI (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2015; AzTrials last refreshed its copy on 30 Oct 2026.