HR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASD (EE-TSA-LANG)

October 15, 2022 updated by: Etablissement Public de Santé Barthélemy Durand

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Étampes, France, 91150
        • Etablissement Public de Santé Barthélemy Durand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Child male or female aged from 3 years to 4 years and half at inclusion with ASD or not.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: EEG-HR
Passation EEG-HR
Diagnostic test: ADI-R
Passation of ADI-R scale
Other Names:
  • AUTISM DIAGNOSTIC INTERVIEW-REVISED
Diagnostic test: ADOS-2
Passation of ADOS-2 scale
Other Names:
  • AUTISM DIAGNOSTIC OBSERVATION SCHEDULE 2
Diagnostic test: IDE
Passation of IDE scale
Other Names:
  • Inventaire du Développement de l'Enfant
  • CDI
  • Child Development Inventory
Diagnostic test: MSEL
Passation of MSEL scale
Other Names:
  • Mullen Scales of Early Learning
Diagnostic test: Dunn
Passation of Dunn scale
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.
Device: EEG-HR
Passation EEG-HR
Diagnostic test: ADI-R
Passation of ADI-R scale
Other Names:
  • AUTISM DIAGNOSTIC INTERVIEW-REVISED
Diagnostic test: ADOS-2
Passation of ADOS-2 scale
Other Names:
  • AUTISM DIAGNOSTIC OBSERVATION SCHEDULE 2
Diagnostic test: IDE
Passation of IDE scale
Other Names:
  • Inventaire du Développement de l'Enfant
  • CDI
  • Child Development Inventory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of speech tracking scores
Time Frame: 4 years
Comparison of speech tracking scores (phases 1 to 3 of the HR EEG recording protocol).
4 years
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.
4 years
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).
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Etablissement Public de Santé Barthélemy Durand

Investigators

  • Principal Investigator: Mariette Vinurel, Etablissement Public de Santé Barthélemy Durand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 2, 2023

Primary Completion (Anticipated)

January 31, 2027

Study Completion (Anticipated)

June 30, 2028

Study Registration Dates

First Submitted

October 15, 2022

First Submitted That Met QC Criteria

October 15, 2022

First Posted (Actual)

October 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 15, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22P01
  • 2022-A01657-36 (Registry Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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