HR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASD
NCT ID: NCT05586672
Last Updated: 2022-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
120 participants
OBSERVATIONAL
2023-01-02
2028-06-30
Brief Summary
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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.
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Detailed Description
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\- 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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
EEG-HR
Passation EEG-HR
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
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.
EEG-HR
Passation EEG-HR
ADI-R
Passation of ADI-R scale
ADOS-2
Passation of ADOS-2 scale
IDE
Passation of IDE scale
Interventions
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EEG-HR
Passation EEG-HR
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
3 Years
4 Years
ALL
Yes
Sponsors
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Etablissement Public de Santé Barthélemy Durand
OTHER
Responsible Party
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Principal Investigators
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Mariette Vinurel
Role: PRINCIPAL_INVESTIGATOR
Etablissement Public de Santé Barthélemy Durand
Locations
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Etablissement Public de Santé Barthélemy Durand
Étampes, , France
Countries
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Central Contacts
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Other Identifiers
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2022-A01657-36
Identifier Type: REGISTRY
Identifier Source: secondary_id
22P01
Identifier Type: -
Identifier Source: org_study_id
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