Autism Spectrum DisorderEE-TSA-LANGNCT05586672
HR-EEG Contribution in Prognostic Evaluation of Language Development in Children With ASD
An observational study of Autism Spectrum Disorder and Language Development, run by Etablissement Public de Santé Barthélemy Durand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Language Development, Neurocognitive Disorders
- What is being tested?
- EEG-HR, ADI-R and ADOS-2
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2023to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Child male or female aged from 3 years to 4 years and half at inclusion with ASD or not.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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).
- Being tested
- EEG-HR, ADI-R, ADOS-2, IDE, MSEL
- Keywords
- High Resolution electroencephalogram, Child, Autism Spectrum Disorder, Language
- Medical subject headings
- Autism Spectrum Disorder, Neurocognitive Disorders, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG-HRDevice
Passation EEG-HR
ADI-RDiagnostic test
Also called AUTISM DIAGNOSTIC INTERVIEW-REVISED
Passation of ADI-R scale
ADOS-2Diagnostic test
Also called AUTISM DIAGNOSTIC OBSERVATION SCHEDULE 2
Passation of ADOS-2 scale
IDEDiagnostic test
Also called Inventaire du Développement de l'Enfant, CDI, Child Development Inventory
Passation of IDE scale
MSELDiagnostic test
Also called Mullen Scales of Early Learning
Passation of MSEL scale
DunnDiagnostic test
Passation of Dunn scale
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EEG-HR; Diagnostic Test: ADI-R; Diagnostic Test: ADOS-2; Diagnostic Test: IDE; Diagnostic Test: MSEL; Diagnostic Test: Dunn | |
| 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. Receives: Device: EEG-HR; Diagnostic Test: ADI-R; Diagnostic Test: ADOS-2; Diagnostic Test: IDE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 4 years
Secondary outcomes (3)
Comparison of speech tracking scores
Comparison of speech tracking scores (phases 1 to 3 of the HR EEG recording protocol).
Measured: 4 years
Evolution of the predictive model
Evolution of the predictive model by integrating data: clinical, longitudinal evolution of speech tracking, deviation from the mean of the control group speech tracking and evolution of speech tracking.
Measured: 4 years
Measures of association by synchronous and diachronic analyses
Measures of association by synchronous and diachronic analyses (mixed generalized linear models for repeated measures).
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start2 Jan 2023 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Etablissement Public de Santé Barthélemy Durand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariette Vinurel, Principal investigator, Etablissement Public de Santé Barthélemy Durand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586672
- Sponsor's protocol ID
- 22P01
- Other IDs
- 2022-A01657-36
- Acronym
- EE-TSA-LANG
- Status last verified
- Oct 2022
- First submitted
- 15 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Electroencephalogram Contribution in Prognostic Evaluation of Language Development in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05586672
- Acronym / sponsor ID
- EE-TSA-LANG / 22P01
- Keywords
- High Resolution electroencephalogram, Child, Autism Spectrum Disorder, Language
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Etablissement Public de Santé Barthélemy DurandUniversity, hospital or other
- Study start
- 2 Jan 2023 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | Device: EEG-HR, Diagnostic Test: ADI-R, Diagnostic Test: ADOS-2, Diagnostic Test: IDE, Diagnostic Test: MSEL, Diagnostic Test: DunnParticipants 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 | – | Device: EEG-HR, Diagnostic Test: ADI-R, Diagnostic Test: ADOS-2, Diagnostic Test: IDEParticipants 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. |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Child male or female aged from 3 years to 4 years and half at inclusion with ASD or not.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEG-HRPassation EEG-HR | Device | ASD group, Control group |
| ADI-RAlso: AUTISM DIAGNOSTIC INTERVIEW-REVISEDPassation of ADI-R scale | Diagnostic test | ASD group, Control group |
| ADOS-2Also: AUTISM DIAGNOSTIC OBSERVATION SCHEDULE 2Passation of ADOS-2 scale | Diagnostic test | ASD group, Control group |
| IDEAlso: Inventaire du Développement de l'Enfant, CDI, Child Development InventoryPassation of IDE scale | Diagnostic test | ASD group, Control group |
| MSELAlso: Mullen Scales of Early LearningPassation of MSEL scale | Diagnostic test | ASD group |
| DunnPassation of Dunn scale | Diagnostic test | ASD group |
Primary outcome
Ability to discriminate children language development
Time frame: 4 years
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).
3 secondary outcomes
Comparison of speech tracking scores
Time frame: 4 years
Evolution of the predictive model
Time frame: 4 years
Measures of association by synchronous and diachronic analyses
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariette Vinurel principal investigator
Etablissement Public de Santé Barthélemy Durand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder and Language Development, run by Etablissement Public de Santé Barthélemy Durand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adelaide Aduayi (+33 1 75 02 16 81, adelaide.aduayi@eps-etampes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to discriminate children language development (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.