Developmental Language Difficulties: Behavioural and Electrophysiological Studies

Dyslexia Clinical Trial

— LANGAGE  

Official title:

Developmental Language Difficulties: Behavioural and Electrophysiological Studies of the Connections Between Spoken and Written Language and Specificity of These Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872870
• Other study ID #: RC-P0020
• Status: Completed
• Phase: N/A
• First received: August 16, 2016
• Last updated: August 16, 2016
• Start date: March 2012
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: June 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aphasia
• Dyslexia
• Dysphasia

Intervention

Behavioral:
• auditory lexical decision task

Device:
• electroencephalogram

Locations

Country	Name	City	State
Belgium	Université catholique de Louvain (IPSY)	Louvain-la-Neuve
France	Hôpital Saint Vincent de Paul (GHICL)	Lille
France	Université de Lille 3 Charles de Gaulle (URECA)	Villeneuve d'Ascq

Sponsors (3)

Lead Sponsor	Collaborator
Lille Catholic University	Université Catholique de Louvain, Université de Lille 3

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score Alouette reading test	In this test, the participant has to read in a loud voice a text, during three minutes. The final score takes into account the speed and the number of errors. For test performance, clinical groups will be compared with its controls.	at inclusion	No
Primary	Score EVALEC reading test	For test performance, clinical groups will be compared with its controls.	at inclusion	No
Primary	Score silence reading test	A group of letters will be presented and the participant has to say if this letters compose a known word. For test performance, clinical groups will be compared with its controls.	at inclusion	No
Primary	Score of reading comprehension test	For test performance, clinical groups will be compared with its controls.	at inclusion	No
Primary	Score of Khomsi	The objective of this group of different tests is to evaluate comprehension and production of oral language. For test performance, clinical groups will be compared with its controls.	at inclusion	No
Secondary	Measure of the electroencephalography power spectra	For test performance, clinical groups will be compared with its controls.	at inclusion	No
Secondary	Correlation between electroencephalography power spectra and clinical outcome	For test performance, clinical groups will be compared with its controls.	at inclusion	No