HR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EEG-HR, ADI-R, ADOS-2, IDE.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder, Language Development, Neurocognitive Disorders, Child Language. Basic parameters: 3 years — 4 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
High Resolution Electroencephalogram Contribution in Prognostic Evaluation of Language Development in Children With Autism Spectrum Disorder
Overview
The goal of this prospective observational multicentric cohort study is to evaluate the clinical prognostic value of the speech tracking score of language development in children with ASD aged from 3 years to 4 years and half at inclusion. Participants will followed during 4 years with an annual visit. During these visits, each participant will be clinically evaluated (scales and tests) and performed an EEG-HR recording. Two groups will be formed, one with children diagnosed with ASD with language delay, and a control group composed of non-ASD children without language delay, matched on age and gender with the ASD group.
Detailed description
Two groups will be formed, one with children diagnosed with ASD with language delay, and a control group composed of non-ASD children without language delay, matched on age and gender with the ASD group.
\- ASD group : For children in the ASD group, 4 visits were planned (inclusion visit, then at one year, two years and three years).
During study visit, each child will be clinically evaluated with standardized scales and tests and will performed an EEG-HR recording while listening to successive soundtracks (modulated pure tones, synthetic voice, recorded voice, real voice, with congruent and non-congruent pictorial supports).
\- Control group : For children in the control group, 1 visit was planned : data will be collected at the inclusion visit only.
During this visit, each child will be clinically evaluated with standardized scales and tests and will performed an EEG-HR recording while listening to successive soundtracks (modulated pure tones, synthetic voice, recorded voice, real voice, with congruent and non-congruent pictorial supports).
Interventions
- Device EEG-HR
Passation EEG-HR - Diagnostic test ADI-R
Passation of ADI-R scale - Diagnostic test ADOS-2
Passation of ADOS-2 scale - Diagnostic test IDE
Passation of IDE scale - Diagnostic test MSEL
Passation of MSEL scale - Diagnostic test Dunn
Passation of Dunn scale
Primary outcome measures
- Ability to discriminate children language development [Time frame: 4 years]
Secondary outcome measures (3)
- Comparison of speech tracking scores [Time frame: 4 years]
- Evolution of the predictive model [Time frame: 4 years]
- Measures of association by synchronous and diachronic analyses [Time frame: 4 years]
Eligibility criteria
Inclusion criteria
For all participants
- Child aged from 3 years to 4 years and half at inclusion.
- Information delivered and no parental objection for study participation.
For ASD group
- Diagnosis of ASD according to DSM-V criteria.
- Expressive language level < 27 months regarding on IDE scale.
For Control group - Matched on age (at +/- 3 months) and gender to ASD group participants.
Exclusion criteria
For all participants
- Any illness or treatment that could significantly alter EEG-HR recording (epilepsy, anti-epileptic treatment, psychotropic drugs...).
- Major hearing or vision disorders.
For ASD group
\- Severe and characterised neurological pathology other than ASD
For Control group
- Characterised neurological or psychiatric pathology.
- Characteristic language delay.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Etablissement Public de Santé Barthélemy Durand — Étampes
Identifiers
NCT: NCT05586672 · 22P01 · 2022-A01657-36