HR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASD
EE-TSA-LANG
High Resolution Electroencephalogram Contribution in Prognostic Evaluation of Language Development in Children With Autism Spectrum Disorder
2 other identifiers
observational
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2022
CompletedFirst Posted
Study publicly available on registry
October 19, 2022
CompletedStudy Start
First participant enrolled
January 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2028
October 19, 2022
October 1, 2022
4.1 years
October 15, 2022
October 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Comparison of speech tracking scores
4 years
Evolution of the predictive model
4 years
Measures of association by synchronous and diachronic analyses
4 years
Study Arms (2)
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.
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.
Interventions
Passation of ADI-R scale
Passation of ADOS-2 scale
Passation of IDE scale
Eligibility Criteria
Child male or female aged from 3 years to 4 years and half at inclusion with ASD or not.
You may qualify if:
- For all participants
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Etablissement Public de Santé Barthélemy Durand
Étampes, 91150, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariette Vinurel
Etablissement Public de Santé Barthélemy Durand
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2022
First Posted
October 19, 2022
Study Start
January 2, 2023
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
June 30, 2028
Last Updated
October 19, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share