Clinical trial NCT02872870: Developmental Language Difficulties: Behavioural and Electrophysiological Studies
Official title: Developmental Language Difficulties: Behavioural and Electrophysiological Studies of the Connections Between Spoken and Written Language and Specificity of These Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslexia
Dysphasia
Keywords: language disorders
developmental disorders of oral and written language
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Université de Lille 3
name: Université Catholique de Louvain
First posted: 2016-08-19
Enrollment: 196
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of 3 groups. A group of volunteers (controls), a group of patients with oral language disorders, a group of patients with written language disorders.

Brief summary: This study will help to better characterize oral and written language disorders and determine if these disorders are continuous or not. The participants ( dyslexic and dysphasic patients and control adults) will carry out an auditory lexical decision task during which an electroencephalogram (EEG) will be recorded.


Eligibility criteria: Inclusion Criteria (patients):

* Non-verbal intelligence quotient (IQ) less than 85 according to the Wechsler Intelligence Scale for Children (WISC) perceptual index
* Specific oral language disorders diagnosed by the multidisciplinary team (neurologist, psychologist, speech therapist): understanding language deficit, estimated by the test SCOTLAND (Lecocq, 1996) and / or vocabulary test (Dunn Thiébaud).
* Specific written language disorders (dyslexia) diagnosed by a multidisciplinary team according to a test that can objectify the late reading (Alouette) and locate deficits (EVALEC)
* Be affiliated to a social security regimen
* Have signed an informed consent or signed by the parents if the patient is minor
* Aged at least 8 years old

Inclusion Criteria (controls)

* Non-deficit (\>85) non-verbal Wechsler Scale (codes and matrices)
* No specific oral language disorders
* No specific written language disorders (dyslexia)
* Be affiliated to a social security regimen
* Have signed an informed consent or signed by the parents if the patient is minor
* Aged at least 8 years old

Exclusion Criteria:

* Mother tongue other than French
* Non-verbal reasoning abilities below 85 measured by the WISC 4 (for patients only) and Non-verbal capacities of reasoning lower than the normal measured by the non-verbal scale of Wechsler (for controls only)
* Presence of pervasive developmental disorders
* No affiliation to a social security regimen
* Absence of signature of the informed consent
* Subject of less than 8 years

Primary outcomes:
measure: Score Alouette reading test
timeFrame: at inclusion
measure: Score EVALEC reading test
timeFrame: at inclusion
measure: Score silence reading test
timeFrame: at inclusion
measure: Score of reading comprehension test
timeFrame: at inclusion
measure: Score of Khomsi
timeFrame: at inclusion
Secondary outcomes:
measure: Measure of the electroencephalography power spectra
timeFrame: at inclusion
measure: Correlation between electroencephalography power spectra and clinical outcome
timeFrame: at inclusion
Other outcomes:
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: Université catholique de Louvain (IPSY)
city: Lille
country: France
facility: Hôpital Saint Vincent de Paul (GHICL)
city: Villeneuve d'Ascq
country: France
facility: Université de Lille 3 Charles de Gaulle (URECA)
Study officials:
affiliation: Université de Lille 3
name: Séverine Casalis
role: STUDY_DIRECTOR
affiliation: Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
name: Françoise Boidein, MD
role: PRINCIPAL_INVESTIGATOR
References: