Developmental Language Difficulties: Behavioural and Electrophysiological Studies (LANGAGE)

August 16, 2016 updated by: Lille Catholic University

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

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

196

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Louvain-la-Neuve, Belgium, 1348
        • Université catholique de Louvain (IPSY)
      • Lille, France, 59000
        • Hôpital Saint Vincent de Paul (GHICL)
      • Villeneuve d'Ascq, France, 59653
        • Université de Lille 3 Charles de Gaulle (URECA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control adults
lexical tests and electroencephalogram (EEG).
Dyslexic patients
lexical tests
Dysphasic patients
lexical tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score Alouette reading test
Time Frame: at inclusion
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
Time Frame: at inclusion
For test performance, clinical groups will be compared with its controls.
at inclusion
Score silence reading test
Time Frame: at inclusion
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
Time Frame: at inclusion
For test performance, clinical groups will be compared with its controls.
at inclusion
Score of Khomsi
Time Frame: at inclusion
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure of the electroencephalography power spectra
Time Frame: at inclusion
For test performance, clinical groups will be compared with its controls.
at inclusion
Correlation between electroencephalography power spectra and clinical outcome
Time Frame: at inclusion
For test performance, clinical groups will be compared with its controls.
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Séverine Casalis, Université de Lille 3
  • Principal Investigator: Françoise Boidein, MD, Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

August 16, 2016

First Submitted That Met QC Criteria

August 16, 2016

First Posted (ESTIMATE)

August 19, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2016

Last Update Submitted That Met QC Criteria

August 16, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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