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

Etablissement Public de Santé Barthélemy Durand

Status: Not yet enrolling

Conditions: Child Language; Autism Spectrum Disorder; Language Development; Neurocognitive Disorders

Treatments: Device: EEG-HR; Diagnostic Test: Dunn; Diagnostic Test: ADOS-2; Diagnostic Test: IDE; Diagnostic Test: ADI-R; Diagnostic Test: MSEL

Study type: Observational

Funder types: Other

Identifiers

NCT05586672

2022-A01657-36 (Registry Identifier)

22P01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 3 to 4 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

ASD group

Description:

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.

Treatment:

Diagnostic Test: MSEL

Diagnostic Test: ADI-R

Diagnostic Test: IDE

Device: EEG-HR

Diagnostic Test: Dunn

Diagnostic Test: ADOS-2

Control group

Description:

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.

Treatment:

Diagnostic Test: ADI-R

Diagnostic Test: IDE

Device: EEG-HR

Diagnostic Test: ADOS-2