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

Autism Spectrum Disorder Clinical Trial

— EE-TSA-LANG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05586672
• Other study ID #: 22P01
• Secondary ID: 2022-A01657-36
• Status: Not yet recruiting
• Start date: January 2, 2023
• Est. completion date: June 30, 2028

Study information

• Verified date: October 2022
• Source: Etablissement Public de Santé Barthélemy Durand
• Contact: Adelaide Aduayi
• Phone: +33 1 75 02 16 81
• Email: adelaide.aduayi[@]eps-etampes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 30, 2028
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 4 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Child Language
• Disease
• Language Development
• Neurocognitive Disorders

Intervention

Device:
• EEG-HR
Passation EEG-HR

Diagnostic Test:
• ADI-R
Passation of ADI-R scale
• ADOS-2
Passation of ADOS-2 scale
• IDE
Passation of IDE scale
• MSEL
Passation of MSEL scale
• Dunn
Passation of Dunn scale

Locations

Country	Name	City	State
France	Etablissement Public de Santé Barthélemy Durand	Étampes

Sponsors (1)

Lead Sponsor	Collaborator
Etablissement Public de Santé Barthélemy Durand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability to discriminate children language development	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).	4 years
Secondary	Comparison of speech tracking scores	Comparison of speech tracking scores (phases 1 to 3 of the HR EEG recording protocol).	4 years
Secondary	Evolution of the predictive model	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.	4 years
Secondary	Measures of association by synchronous and diachronic analyses	Measures of association by synchronous and diachronic analyses (mixed generalized linear models for repeated measures).	4 years