NCT05586672Not yet recruiting
HR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASD
High Resolution Electroencephalogram Contribution in Prognostic Evaluation of Language Development in Children With Autism Spectrum Disorder
Source: ClinicalTrials.gov · Last updated 19 Oct 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 15 Oct 2022
- Start date
- 2 Jan 2023
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Etablissement Public de Santé Barthélemy Durand
- Diseases
- Autism
- NCT number
- NCT05586672
What you commit to
- Study type: Observational
- Planned participants: 120
- From 2 Jan 2023 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- For all participants
- Characteristic language delay.
Who the study is looking for
- 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.
Age in the registry: 3 years to 4 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Etablissement Public de Santé Barthélemy Durand Coordinator of this site? Confirm its status | Étampes | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.