- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02609542
Memorisation of Phonologic Information Among Children With Oral Language Developement Disorder (MEMENTO)
Coding and Memorisation of Phonologic Information Among Preschool and School Children With Oral Language Developement Disorder.
The disorder of oral language development is defined by the delay in language acquisition in children who possess efficient auditory acuity and normal non verbal intellect.
The diversity of language developement disorders depends either in the expressive level or in the receptive level leading to divers syndromes and symptoms. These syndromes and symptoms are regrouped under the name of STOL (Specific Troubles of Oral Language).
In the current project the visual exploitation and learning capability of children presenting a STOL condition will be compared to patients with a normal development. The investigator's hypothesis is as follows: STOL patients for whom the STOL disorder is reduced between 4 and 7 years of age will present a better performance at verbal memorisation, compared to patients with a persistent STOL condition after the age of 6.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Amélie Lansiaux, MD, PhD
- Email: lansiaux.amelie@ghicl.net
Study Contact Backup
- Name: Mélanie Hamez, Med Monitor
- Email: hamez.melanie@ghicl.net
Study Locations
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Nord-Pas-de-Calais
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Lille, Nord-Pas-de-Calais, France, 59000
- Recruiting
- Hôpital St Vincent-de-Paul (GHICL)
-
Contact:
- Delphine Fleurion, MD
- Phone Number: +0033623531011 +0033320874223
- Email: delphine.fleurion@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria for STOL patients:
- Child aged between 45 and 95 months at inclusion
- A score > or equal to 5 percentile on the non verbal intelligence test (PM47)
- Patient diagnosed with STOL by the neuropediatric medical team
- Coverage of the social insurance
- Consent form signed by the parents or the legal representative of the child
- Normal or corrected sight
- Normal hearing
Inclusion Criteria for control patients:
- Child aged between 45 and 95 months on the day of inclusion
- A score > or equal to 5 percentile on the non verbal intelligence test (PM47)
- Child who did not receive any speech therapy
- Coverage of the social insurance
- Consent form signed by the parents or the legal representative of the child
- Normal or corrected sight
- Normal hearing
Exclusion Criteria for STOL patients:
- Mother language other than French
- Score < to 5 percentile on the non verbal intelligence test (PM47)
- Child with pervasive developmental disorder
Exclusion Criteria for control patients:
- Mother language other than French
- Score < to 5 percentile on the non verbal intelligence test (PM47)
- Child who received speech therapy
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
STOL group
STOL children will be recruited in the neuropediatric unit at the GHICL in Lille. Children will be followed and we will determine if capacities of verbal memory of the children presenting STOL diagnosed at an early stage of their development (before 6 years) are predictive of the evolution of the disorder according to their cognitive profile and more specifically, their language profile as well as their tests performances. The participants' eye movements ( visual world paradigm or eye tracking) will be recorded in order to determine the interplay between linguistic and visual information processing. Patients with a persistent STOL will be identified at the end of the follow up. |
Eye tracker will allows the recording of various information concerning eye fixation (number, duration, location) and saccadic eye movement (speed, range, number, duration) in order to determine the interplay between linguistic and visual information processing during tests performance
Other Names:
|
Control group
Children with no language development disorder willing to participate in the study will be recruited at school.
The participants' eye movements ( visual world paradigm or eye tracking) will be recorded in order to determine the interplay between linguistic and visual information processing.
|
Eye tracker will allows the recording of various information concerning eye fixation (number, duration, location) and saccadic eye movement (speed, range, number, duration) in order to determine the interplay between linguistic and visual information processing during tests performance
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in the score associated to speech-language outcome measured by a scale grouping results of different questionnaires
Time Frame: 0,12, 24 months
|
We will determine if capacities of verbal memory of the children presenting STOL diagnosed at an early stage of their development (before 6 years) are predictive of the evolution of the disorder according to their cognitive profile and more specifically, their language profile as well as their tests performances.
To measure the speech language outcome is necessary to take in consideration the score of more than one test performance.
|
0,12, 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in the Raven's Progressive Matrices (RPM) test
Time Frame: 0,12, 24 months
|
Raven's Progressive Matrices (RPM) is a test often used in educational settings that is comprised of 60 multiple choice questions.
This is a nonverbal test in that the questions are comprised of visual patterns.
RPM measures the ability to think clearly about complex ideas and the ability to store and recall information.
|
0,12, 24 months
|
Changes from baseline in the Peabody Picture Vocabulary Test
Time Frame: 0,12, 24 months
|
The Peabody Picture Vocabulary Test measures an individual's receptive (hearing) vocabulary and provides, at the same time, a quick estimate of verbal ability or scholastic aptitude.
|
0,12, 24 months
|
Changes from baseline in the number repetition test
Time Frame: 0,12, 24 months
|
0,12, 24 months
|
|
Changes from baseline in the sentences repetition test
Time Frame: 0,12, 24 months
|
0,12, 24 months
|
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Changes from baseline in the non-words repetition test
Time Frame: 0,12, 24 months
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0,12, 24 months
|
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Changes from baseline in the children's eye tracking
Time Frame: 0,12, 24 months
|
It is done in order to determine if their is a relation between the evolution of processes involved in verbal memorisation (cognitive mechanisms in charge of data processing). Eye tracker will allow the recording of information regarding eye fixation (number, duration, location) and saccadic eye movements (speed, range, number, duration) in order to determine the interplay between linguistic and visual information processing during test performances. |
0,12, 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Delphine Fleurion, Psychologist, Groupement des Hôpitaux de l'institut Catholique de Lille
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC-P0029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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