Ignite Creation Date:
2024-05-06 @ 6:12 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05586672
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-10-19
First Post:
2022-10-15
Brief Title:
HR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASD
Sponsor:
Etablissement Public de Santé Barthélemy Durand
Organization:
Etablissement Public de Santé Barthélemy Durand
Study Overview
Official Title:
High Resolution Electroencephalogram Contribution in Prognostic Evaluation of Language Development in Children With Autism Spectrum Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EE-TSA-LANG
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
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
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
- 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A01657-36 | REGISTRY | ANSM | None |