Clinical trial NCT05586672: HR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASD
Official title: High Resolution Electroencephalogram Contribution in Prognostic Evaluation of Language Development in Children With Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autism Spectrum Disorder
Language Development
Neurocognitive Disorders
Child Language
Keywords: High Resolution electroencephalogram
Child
Autism Spectrum Disorder
Language
Lead sponsor: Etablissement Public de Santé Barthélemy Durand
Sponsor class: OTHER
First posted: 2022-10-19
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Child male or female aged from 3 years to 4 years and half at inclusion with ASD or not.

Brief summary: 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).

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.

Primary outcomes:
measure: Ability to discriminate children language development
timeFrame: 4 years
Secondary outcomes:
measure: Comparison of speech tracking scores
timeFrame: 4 years
measure: Evolution of the predictive model
timeFrame: 4 years
measure: Measures of association by synchronous and diachronic analyses
timeFrame: 4 years
Other outcomes:
Locations:
city: Étampes
country: France
facility: Etablissement Public de Santé Barthélemy Durand
Study officials:
affiliation: Etablissement Public de Santé Barthélemy Durand
name: Mariette Vinurel
role: PRINCIPAL_INVESTIGATOR
References: