- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02872870
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
Status
Completed
Intervention / Treatment
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.
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC-P0020
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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