HR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASD

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.

Full Title of Study: “High Resolution Electroencephalogram Contribution in Prognostic Evaluation of Language Development in Children With Autism Spectrum Disorder”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: January 31, 2027

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

Arms, Groups and Cohorts

• ASD group
  • Participants aged from 3 years to 4 years and half at inclusion will be clinically evaluated with standardized scales and tests and will performed an EEG-HR recording while listening to successive soundtracks at several times.
• Control group
  • Participants aged from 3 years to 4 years and half at inclusion will be clinically evaluated with standardized scales and tests and will performed an EEG-HR recording while listening to successive soundtracks in inclusion visit.

Clinical Trial Outcome Measures

Primary Measures

• Ability to discriminate children language development
  • Time Frame: 4 years
  • The primary endpoint is the ability to discriminate children whose language development will be favourable (developmental level ≥ 27 months) from those whose language development will be unfavourable (< 27 months) based on the speech tracking measure (on the EEG-HR at inclusion).

Secondary Measures

• Comparison of speech tracking scores
  • Time Frame: 4 years
  • Comparison of speech tracking scores (phases 1 to 3 of the HR EEG recording protocol).
• Evolution of the predictive model
  • Time Frame: 4 years
  • Evolution of the predictive model by integrating data: clinical, longitudinal evolution of speech tracking, deviation from the mean of the control group speech tracking and evolution of speech tracking.
• Measures of association by synchronous and diachronic analyses
  • Time Frame: 4 years
  • Measures of association by synchronous and diachronic analyses (mixed generalized linear models for repeated measures).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 4 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Etablissement Public de Santé Barthélemy Durand
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Mariette Vinurel, Principal Investigator, Etablissement Public de Santé Barthélemy Durand
• Overall Contact(s)
  • Adelaide Aduayi, +33 1 75 02 16 81, adelaide.aduayi@eps-etampes.fr