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Trial record 35 of 60 for:    Dyslexia

Developmental Language Difficulties: Behavioural and Electrophysiological Studies (LANGAGE)

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ClinicalTrials.gov Identifier: NCT02872870
Recruitment Status : Completed
First Posted : August 19, 2016
Last Update Posted : August 19, 2016
Sponsor:
Collaborators:
Université de Lille 3
Université Catholique de Louvain
Information provided by (Responsible Party):
Lille Catholic University

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.

Condition or disease Intervention/treatment
Dyslexia Dysphasia Behavioral: auditory lexical decision task Device: electroencephalogram

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Study Type : Observational
Actual Enrollment : 196 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Developmental Language Difficulties: Behavioural and Electrophysiological Studies of the Connections Between Spoken and Written Language and Specificity of These Disorders
Study Start Date : March 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : June 2016

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. Score EVALEC reading test [ Time Frame: at inclusion ]
    For test performance, clinical groups will be compared with its controls.

  3. 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.

  4. Score of reading comprehension test [ Time Frame: at inclusion ]
    For test performance, clinical groups will be compared with its controls.

  5. 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.


Secondary Outcome Measures :
  1. Measure of the electroencephalography power spectra [ Time Frame: at inclusion ]
    For test performance, clinical groups will be compared with its controls.

  2. Correlation between electroencephalography power spectra and clinical outcome [ Time Frame: at inclusion ]
    For test performance, clinical groups will be compared with its controls.



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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872870


Locations
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Belgium
Université catholique de Louvain (IPSY)
Louvain-la-Neuve, Belgium, 1348
France
Hôpital Saint Vincent de Paul (GHICL)
Lille, France, 59000
Université de Lille 3 Charles de Gaulle (URECA)
Villeneuve d'Ascq, France, 59653
Sponsors and Collaborators
Lille Catholic University
Université de Lille 3
Université Catholique de Louvain
Investigators
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Study Director: Séverine Casalis Université de Lille 3
Principal Investigator: Françoise Boidein, MD Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)

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Responsible Party: Lille Catholic University
ClinicalTrials.gov Identifier: NCT02872870     History of Changes
Other Study ID Numbers: RC-P0020
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lille Catholic University:
language disorders
developmental disorders of oral and written language

Additional relevant MeSH terms:
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Dyslexia
Aphasia
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Learning Disorders
Signs and Symptoms
Neurodevelopmental Disorders
Mental Disorders
Speech Disorders