Loading clinical trials...
Loading clinical trials...
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.
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).
Age
3 - 4 years
Sex
ALL
Healthy Volunteers
Yes
Etablissement Public de Santé Barthélemy Durand
Étampes, France
Start Date
January 2, 2023
Primary Completion Date
January 31, 2027
Completion Date
June 30, 2028
Last Updated
October 19, 2022
120
ESTIMATED participants
EEG-HR
DEVICE
ADI-R
DIAGNOSTIC_TEST
ADOS-2
DIAGNOSTIC_TEST
IDE
DIAGNOSTIC_TEST
MSEL
DIAGNOSTIC_TEST
Dunn
DIAGNOSTIC_TEST
Lead Sponsor
Etablissement Public de Santé Barthélemy Durand
NCT06290258
NCT05750095
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05508789