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

Not yet recruiting

• Conditions: Autism Spectrum Disorder; Child Language; Neurocognitive Disorders; Language Development
• Interventions: Device: EEG-HR; Diagnostic Test: ADI-R; Diagnostic Test: ADOS-2; Diagnostic Test: IDE; Diagnostic Test: MSEL; Diagnostic Test: Dunn

• Registration Number: NCT05586672
• Lead Sponsor: Etablissement Public de Santé Barthélemy Durand

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).

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-15
• Study First Submitted QC: 2022-10-15
• Last Update Submitted: 2022-10-15
• Study First Posted: 2022-10-19
• Last Update Posted: 2022-10-19
• Study Start: 2023-01-02
• Primary Completion: 2027-01-31
• Study Completion: 2028-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ASD group	EEG-HR	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.
ASD group	IDE	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.
ASD group	Dunn	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	ADOS-2	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.
Control group	EEG-HR	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.
ASD group	MSEL	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.
ASD group	ADI-R	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.
ASD group	ADOS-2	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	IDE	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.
Control group	ADI-R	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.

Primary Outcome Measures

Name	Time	Method
Ability to discriminate children language development	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 Outcome Measures

Name	Time	Method
Evolution of the predictive model	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.
Comparison of speech tracking scores	4 years	Comparison of speech tracking scores (phases 1 to 3 of the HR EEG recording protocol).
Measures of association by synchronous and diachronic analyses	4 years	Measures of association by synchronous and diachronic analyses (mixed generalized linear models for repeated measures).

Trial Locations

Locations (1)

Etablissement Public de Santé Barthélemy Durand; 🇫🇷 Étampes, France