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NCT Number: NCT05586672

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

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.

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Key information

Age range

3 year–4 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Etablissement Public de Santé Barthélemy Durand

Étampes, 91150, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EEG-HR

Device

Passation EEG-HR

ADI-R

Diagnostic Test

Passation of ADI-R scale

Other names: AUTISM DIAGNOSTIC INTERVIEW-REVISED

ADOS-2

Diagnostic Test

Passation of ADOS-2 scale

Other names: AUTISM DIAGNOSTIC OBSERVATION SCHEDULE 2

IDE

Diagnostic Test

Passation of IDE scale

Other names: Inventaire du Développement de l'Enfant, CDI, Child Development Inventory

MSEL

Diagnostic Test

Passation of MSEL scale

Other names: Mullen Scales of Early Learning

Dunn

Diagnostic Test

Passation of Dunn scale

Primary outcomes

  1. 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 outcomes

  1. Comparison of speech tracking scores

    Time frame: 4 years

    Comparison of speech tracking scores (phases 1 to 3 of the HR EEG recording protocol).

  2. 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.

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Adelaide Aduayi

CONTACT

[email protected]

+33 1 75 02 16 81

Morgane Da Silva Hennequin

CONTACT

[email protected]

+33 1 82 26 81 08

Sponsors and collaborators

Lead sponsor

Etablissement Public de Santé Barthélemy Durand

Other

Registry information

Official study title

High Resolution Electroencephalogram Contribution in Prognostic Evaluation of Language Development in Children With Autism Spectrum Disorder

Acronym: EE-TSA-LANG

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 19, 2022
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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