Developmental Language Difficulties: Behavioural and Electrophysiological Studies

NCT02872870 | Completed

• 1 other identifier: RC-P0020
• Study Type: observational
• Target: 196
• Locations: 2 countries
• Sites: 3

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.

Conditions

Dyslexia; Dysphasia

Keywords

language disorders; developmental disorders of oral and written language

Outcome Measures

Primary Outcomes (5)

• 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

• Score EVALEC reading test

  For test performance, clinical groups will be compared with its controls.

  at inclusion

• 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

• Score of reading comprehension test

  For test performance, clinical groups will be compared with its controls.

  at inclusion

• 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

Secondary Outcomes (2)

• Measure of the electroencephalography power spectra

  at inclusion

• Correlation between electroencephalography power spectra and clinical outcome

  at inclusion

Study Arms (3)

Control adults

lexical tests and electroencephalogram (EEG).

Behavioral: auditory lexical decision task; Device: electroencephalogram

Dyslexic patients

lexical tests

Behavioral: auditory lexical decision task; Device: electroencephalogram

Dysphasic patients

lexical tests

Behavioral: auditory lexical decision task; Device: electroencephalogram

Interventions

auditory lexical decision task BEHAVIORAL

Control adults; Dyslexic patients; Dysphasic patients

electroencephalogram DEVICE

Control adults; Dyslexic patients; Dysphasic patients

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lille Catholic University: lead
• Université de Lille 3: collaborator
• Université Catholique de Louvain: collaborator

Study Sites (3)

Université catholique de Louvain (IPSY)

Louvain-la-Neuve, 1348, Belgium

Location

Hôpital Saint Vincent de Paul (GHICL)

Lille, 59000, France

Location

Université de Lille 3 Charles de Gaulle (URECA)

Villeneuve-d'Ascq, 59653, France

Location

MeSH Terms

Conditions

Dyslexia; Aphasia; Language Disorders

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Specific Learning Disorder; Learning Disabilities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Speech Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Séverine Casalis

  Université de Lille 3

  STUDY DIRECTOR

• Françoise Boidein, MD

  Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 19, 2016
• Study Start: March 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 19, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); FR (2)