Neurofibromatosis Type 1NCT03518710
Vision, Attention and Reading in Neurofibromatosis Type 1 (NF1) Children
A study testing Neuropsychological evaluation and Evaluation of the reading assistance technique in people with Neurofibromatosis Type 1, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The present project will therefore focus upon those processes related to visual attention and perceptual abilities and on their potential to explain reading behavior and reading problems in NF1. Read more about this study
- Who is it for?
- Ages 7 to 9 years
- Conditions the study is for
- Neurofibromatosis Type 1
- What is being tested?
- Neuropsychological evaluation and Evaluation of the reading assistance technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2018to May 2019
- 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 7 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child with a NF1 following the clinically-based criteria agreed at the international Consensus Conference
- Age between 7 and 9 years old child in 1st - 3rd grades with 5 children/grade
- Informed children and written consent obtained from one of the parents or other lawful representative
- Child who is covered by the social security scheme
Who cannot join
- left-handed children
- associated neurological disorder such as brain tumors or epilepsy
- mental retardation (IQ <70 or Wechsler Intelligence Scale for Children (WISC) scores SIM et IC < 7)
- children with Autism Spectrum Disorder
- diagnosis of attention deficit hyperactivity disorder (ADHD) (DSM-IV), with presence of hyperactive-impulsive or inattentive symptom
- pharmaceutical treatment (e.g., anti-depressants, anxiolytics)
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital Toulouse
Toulouse, 31059
Yves Chaix, MD, 05 34 55 85 76 ext. 33, chaix.y@chu-toulouse.fr
Isabelle Olivier, MD, 05 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
The present project will therefore focus upon those processes related to visual attention and perceptual abilities and on their potential to explain reading behavior and reading problems in NF1. The main objective of this study is to clarify the specificity and heterogeneity of reading profiles and the causes of its disturbance in NF1. In particular, this project allow the investigators to study more precisely the relations between perceptual, oculomotor and visuo-attentional skills in NF1 children and reading abilities. In addition, a new oculomotor/perceptual reading aid for NF1 children will be evaluated. The investigators believe that the early intervention for perceptual, visuo-attentional or oculomotor problems may promote academic skill development.
Read the detailed description
Although some NF1 children manage in the end to exhibit "expert" reading behavior, a non-negligible number of them have real problems learning this skill. Today's estimates indicate that 30-60% of NF1 children suffer from written-language learning disorder. Studies of the effects of the neurocognitive deficit on academic performance are relatively rare, owing to the small size of the populations concerned. However, research is needed to develop effective rehabilitation programs. At the current time, most tools available to professionals are designed for the evaluation and remediation of child language problems, particularly difficulties related to the acquisition of meta-phonological skills. The findings from dyslexics and typically developing readers however suggest a strong relationship between reading ability and visual processing. The main goal of this study is to investigate the occurrence of perceptual, visuo-attentional and oculomotor deficits in NF1 children and their potential to explain reading behavior and reading problems in this population. The investigators hope to contribute to the process of clarifying the specificity and heterogeneity of reading profiles and the causes of its disturbance in NF1. The second objective of the study is to evaluate an oculomotor/perceptual reading aid for NF1 children; in particular, the idea of the training is to help the readers to land their saccades at the optimal viewing position1 (OVP) of each word (highlighting the letter at the OVP or putting it in color, so that the saccades they make would land near the centre of the word, at the OVP). Eye movement control during reading is a highly automated process; people are not aware of most of the saccades and fixations they make. This tool is a way to train children to control these subconscious saccades and fixations. Note that, our team has already demonstrated the usefulness of this reading aid for beginning readers. This project have important implications from a clinical perspective, by providing the opportunity to gain insight into the reading difficulties of NF1 children, in view of establishing thorough and accurate assessment procedures and proposing child-specific guidelines and remediation methods that take into account the particular processes affected. Providing a clearer picture of visuo-attentional and perceptual skills in children with NF1 would be of considerable clinical benefit, not least for supporting targeted clinical practices. Moreover, NF1 children could benefit from a new remediation tool that allow them to have feedback on their reading ability, and to read more easily, more rapidly, and with better comprehension. If appropriate interventions are implemented at an early age, academic skill development could be altered, preventing subtle learning difficulties from becoming more pronounced over time.
- Conditions
- Neurofibromatosis Type 1
- Being tested
- Neuropsychological evaluation, Evaluation of the reading assistance technique
- Keywords
- child, reading, vision, attention, therapeutical perspectives
- Medical subject headings
- Neurofibromatosis 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological evaluationOther
Neuropsychological evaluation (about 60 min) the same day realized by a student in Science Thesis under the responsibility of Prof. Yves Chaix and including:
- Process evaluation:
- Oculomotors: DEM test (5min)
- Visuo-attention: computerized STROOP (15min)
- Visuo-Perceptive: DTVP3 (30min)
- Phonological \& lexical: Exalang (10min)
Evaluation of the reading assistance techniqueOther
Evaluation of the reading assistance technique (about 30 min) and comprising:
- Reading evaluation:Test lark (3min) Experimental task: 3-way help with reading (without help, color help and highlight help (25 min)
| Study group | Role | What they receive |
|---|---|---|
| Children with NF1 | Experimental | One experimental group of NF1 children with 3 reading levels (1st grade, 2nd grade and 3rd grade). For this research they will pass :
* Neuropsychological evaluation
* Evaluation of the reading assistance technique Receives: Other: Neuropsychological evaluation; Other: Evaluation of the reading assistance technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the score obtained for Oculomotor Processes
The visual process : Oculomotor Processes : Vertical,Horizontal Time with the Ratio with the Developmental Eye Movement Test (DEM test) : a standard of evaluation oculomotor in children with reading difficulties
Measured: 1 day
Evaluation of the composite score obtained for Visuo-perceptual process
The visual process : Visuo-perceptual process : it's a composite score : Composite score of perceptual treatment with pure visual perception score and visuo-motor integration with a Developmental Test of Visual Perception, 3rd (DTVP3) test is Visual perception development test
Measured: 1 day
Evaluation of the score obtained : Visual-attentional process
Visual-attentional process : reaction time (milli Sec) with the percentage of correct answers to the computerized Stroop to show that attention is a selective process and that it is very difficult to read and name colors at the same time
Measured: 1 day
Secondary outcomes (1)
Alouette Reading Test
To evaluate language skills like phonological awareness with lexical stock Alouette Reading Test's aim is for the accuracy index and CTL speed index :The Alouette test is a reading test that evaluates the level of lexical decoding (automaticity). It consists of reading a standard text aloud and count the number of words read and errors in a given time
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study startAug 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
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.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves Chaix, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518710
- Sponsor's protocol ID
- RC31/17/0376
- Other IDs
- 2017-A02907-46
- Status last verified
- Jul 2018
- First submitted
- 23 Apr 2018
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vision, Attention and Reading in Neurofibromatosis Type 1 (NF1) Children
- ClinicalTrials.gov ID
- NCT03518710
- Acronym / sponsor ID
- RC31/17/0376
- Conditions
- Neurofibromatosis Type 1
- Keywords
- child, reading, vision, attention, therapeutical perspectives
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 8 May 2018 (actual)
- 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.
The present project will therefore focus upon those processes related to visual attention and perceptual abilities and on their potential to explain reading behavior and reading problems in NF1. The main objective of this study is to clarify the specificity and heterogeneity of reading profiles and the causes of its disturbance in NF1. In particular, this project allow the investigators to study more precisely the relations between perceptual, oculomotor and visuo-attentional skills in NF1 children and reading abilities. In addition, a new oculomotor/perceptual reading aid for NF1 children will be evaluated. The investigators believe that the early intervention for perceptual, visuo-attentional or oculomotor problems may promote academic skill development.
Detailed description
Although some NF1 children manage in the end to exhibit "expert" reading behavior, a non-negligible number of them have real problems learning this skill. Today's estimates indicate that 30-60% of NF1 children suffer from written-language learning disorder. Studies of the effects of the neurocognitive deficit on academic performance are relatively rare, owing to the small size of the populations concerned. However, research is needed to develop effective rehabilitation programs. At the current time, most tools available to professionals are designed for the evaluation and remediation of child language problems, particularly difficulties related to the acquisition of meta-phonological skills. The findings from dyslexics and typically developing readers however suggest a strong relationship between reading ability and visual processing. The main goal of this study is to investigate the occurrence of perceptual, visuo-attentional and oculomotor deficits in NF1 children and their potential to explain reading behavior and reading problems in this population. The investigators hope to contribute to the process of clarifying the specificity and heterogeneity of reading profiles and the causes of its disturbance in NF1. The second objective of the study is to evaluate an oculomotor/perceptual reading aid for NF1 children; in particular, the idea of the training is to help the readers to land their saccades at the optimal viewing position1 (OVP) of each word (highlighting the letter at the OVP or putting it in color, so that the saccades they make would land near the centre of the word, at the OVP). Eye movement control during reading is a highly automated process; people are not aware of most of the saccades and fixations they make. This tool is a way to train children to control these subconscious saccades and fixations. Note that, our team has already demonstrated the usefulness of this reading aid for beginning readers. This project have important implications from a clinical perspective, by providing the opportunity to gain insight into the reading difficulties of NF1 children, in view of establishing thorough and accurate assessment procedures and proposing child-specific guidelines and remediation methods that take into account the particular processes affected. Providing a clearer picture of visuo-attentional and perceptual skills in children with NF1 would be of considerable clinical benefit, not least for supporting targeted clinical practices. Moreover, NF1 children could benefit from a new remediation tool that allow them to have feedback on their reading ability, and to read more easily, more rapidly, and with better comprehension. If appropriate interventions are implemented at an early age, academic skill development could be altered, preventing subtle learning difficulties from becoming more pronounced over time.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with NF1 | Experimental | Other: Neuropsychological evaluation, Other: Evaluation of the reading assistance techniqueOne experimental group of NF1 children with 3 reading levels (1st grade, 2nd grade and 3rd grade). For this research they will pass : * Neuropsychological evaluation * Evaluation of the reading assistance technique |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Child with a NF1 following the clinically-based criteria agreed at the international Consensus Conference
- Age between 7 and 9 years old child in 1st - 3rd grades with 5 children/grade
- Informed children and written consent obtained from one of the parents or other lawful representative
- Child who is covered by the social security scheme
Key exclusion criteria (6 listed)
- left-handed children
- associated neurological disorder such as brain tumors or epilepsy
- mental retardation (IQ <70 or Wechsler Intelligence Scale for Children (WISC) scores SIM et IC < 7)
- children with Autism Spectrum Disorder
- diagnosis of attention deficit hyperactivity disorder (ADHD) (DSM-IV), with presence of hyperactive-impulsive or inattentive symptom
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 evaluationNeuropsychological evaluation (about 60 min) the same day realized by a student in Science Thesis under the responsibility of Prof. Yves Chaix and including: * Process evaluation: * Oculomotors: DEM test (5min) * Visuo-attention: computerized STROOP (15min) * Visuo-Perceptive: DTVP3 (30min) * Phonological \& lexical: Exalang (10min) | Other | Children with NF1 |
| Evaluation of the reading assistance techniqueEvaluation of the reading assistance technique (about 30 min) and comprising: - Reading evaluation:Test lark (3min) Experimental task: 3-way help with reading (without help, color help and highlight help (25 min) | Other | Children with NF1 |
Primary outcome
Evaluation of the score obtained for Oculomotor Processes
Time frame: 1 day
The visual process : Oculomotor Processes : Vertical,Horizontal Time with the Ratio with the Developmental Eye Movement Test (DEM test) : a standard of evaluation oculomotor in children with reading difficulties
Evaluation of the composite score obtained for Visuo-perceptual process
Time frame: 1 day
The visual process : Visuo-perceptual process : it's a composite score : Composite score of perceptual treatment with pure visual perception score and visuo-motor integration with a Developmental Test of Visual Perception, 3rd (DTVP3) test is Visual perception development test
Evaluation of the score obtained : Visual-attentional process
Time frame: 1 day
Visual-attentional process : reaction time (milli Sec) with the percentage of correct answers to the computerized Stroop to show that attention is a selective process and that it is very difficult to read and name colors at the same time
1 secondary outcome
Alouette Reading Test
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Individual participant dataSharing planned: No
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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 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 evaluation and Evaluation of the reading assistance technique 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yves Chaix, MD (05 34 55 85 76 ext. 33, chaix.y@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the score obtained for Oculomotor Processes (time frame: 1 day). The study lists 3 primary outcomes in all. 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 11 Jul 2018.