NCT05586672

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Etablissement Public de Santé Barthélemy Durand · Academic / Other
• Sex: All
• Age: 3 Years – 4 Years
• Healthy volunteers: Accepted

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).

Conditions

• Autism Spectrum Disorder
• Language Development
• Neurocognitive Disorders
• Child Language

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-02
• Primary completion: 2027-01-31
• Completion: 2028-06-30
• First posted: 2022-10-19
• Last updated: 2022-10-19

Locations

1 site across 1 country: France