DyslexiaLANGAGENCT02872870
Developmental Language Difficulties: Behavioural and Electrophysiological Studies
An observational study of Dyslexia and Dysphasia, run by Lille Catholic University at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- What is being tested?
- auditory lexical decision task and electroencephalogram
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 196 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2012to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Hôpital Saint Vincent de Paul (GHICL)
Lille, 59000
Université de Lille 3 Charles de Gaulle (URECA)
Villeneuve-d'Ascq, 59653
About this study
Official title: 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.
- Being tested
- auditory lexical decision task, electroencephalogram
- Keywords
- language disorders, developmental disorders of oral and written language
- Medical subject headings
- Dyslexia, Aphasia, Language Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auditory lexical decision taskBehavioural
electroencephalogramDevice
| Study group | Role | What they receive |
|---|---|---|
| Control adults | lexical tests and electroencephalogram (EEG). Receives: Behavioral: auditory lexical decision task; Device: electroencephalogram | |
| Dyslexic patients | lexical tests Receives: Behavioral: auditory lexical decision task; Device: electroencephalogram | |
| Dysphasic patients | lexical tests Receives: Behavioral: auditory lexical decision task; Device: electroencephalogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at inclusion
Score EVALEC reading test
For test performance, clinical groups will be compared with its controls.
Measured: 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.
Measured: at inclusion
Score of reading comprehension test
For test performance, clinical groups will be compared with its controls.
Measured: 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.
Measured: at inclusion
Secondary outcomes (2)
Measure of the electroencephalography power spectra
For test performance, clinical groups will be compared with its controls.
Measured: at inclusion
Correlation between electroencephalography power spectra and clinical outcome
For test performance, clinical groups will be compared with its controls.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startMar 2012
- Primary completionMar 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- University Charles-de-Gaulle, Université Catholique de Louvain
- Responsible party
- Sponsor
- Investigators
- Séverine Casalis, Study director, University Charles-de-GaulleFrançoise Boidein, MD, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872870
- Sponsor's protocol ID
- RC-P0020
- Acronym
- LANGAGE
- Status last verified
- Aug 2016
- First submitted
- 16 Aug 2016
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Language Difficulties: Behavioural and Electrophysiological Studies of the Connections Between Spoken and Written Language and Specificity of These Disorders
- ClinicalTrials.gov ID
- NCT02872870
- Acronym / sponsor ID
- LANGAGE / RC-P0020
- Keywords
- language disorders, developmental disorders of oral and written language
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- University Charles-de-Gaulle, Université Catholique de Louvain
- Study start
- Mar 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control adults | – | Behavioral: auditory lexical decision task, Device: electroencephalogramlexical tests and electroencephalogram (EEG). |
| Dyslexic patients | – | Behavioral: auditory lexical decision task, Device: electroencephalogramlexical tests |
| Dysphasic patients | – | Behavioral: auditory lexical decision task, Device: electroencephalogramlexical tests |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auditory lexical decision task | Behavioural | Control adults, Dyslexic patients, Dysphasic patients |
| electroencephalogram | Device | Control adults, Dyslexic patients, Dysphasic patients |
Primary outcome
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.
Score EVALEC reading test
Time frame: at inclusion
For test performance, clinical groups will be compared with its controls.
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.
Score of reading comprehension test
Time frame: at inclusion
For test performance, clinical groups will be compared with its controls.
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.
2 secondary outcomes
Measure of the electroencephalography power spectra
Time frame: at inclusion
Correlation between electroencephalography power spectra and clinical outcome
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Séverine Casalis study director
University Charles-de-Gaulle
Françoise Boidein, MD principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille (GHICL)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyslexia and Dysphasia, run by Lille Catholic University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score Alouette reading test (time frame: at inclusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.