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Not yet recruiting NCT07303413

A Rhythmic and Auditory Approach for Children With Autism Spectrum Disorders (ASD)

No phase Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EEG recording, Picture recognition test.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 3 years — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Approche Rythmique et Auditive Chez Les Enfants Avec Troubles du Spectre de l'Autisme (TSA)

Overview

The aim of this study is to assess the effectiveness of a rhythmic auditory training program in improving language skills in children with Autism Spectrum Disorder (ASD) who have a language acquisition disorder. The program focuses on training children to reproduce the syllable rhythms of speech, and the study will evaluate the children's language skills before and after participating in the program.

Interventions

  • Behavioral EEG recording
    EEG recording while listening to natural sounds
  • Behavioral Picture recognition test
    Children will have 4 images in front of them and a sound recording will be played to tell them which image to choose. They will have to click on the one that corresponds to what was said in the sound recording.

Primary outcome measures

  • The difference in the progression of language acquisition measured by the difference in the number of images recognised in image recognition tests. [Time frame: 12 weeks]
Secondary outcome measures (12)
  • Comparison of Neural tracking of speech via EEG measurements of brain oscillatory activity before and after a session of listening to rhythmic sound. [Time frame: 12 weeks]
  • Comparison of theta/gamma frequency bands via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training [Time frame: 12 weeks]
  • Comparison of Phase Locking Value via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training [Time frame: 12 weeks]
  • Comparison of theta/gamma Phase-amplitude Coupling in auditory cortical areas via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training [Time frame: 12 weeks]
  • correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index. [Time frame: 12 weeks]
  • correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index. [Time frame: 12 weeks]
  • correlation between theta/gamma phase-amplitude coupling via EEG measurements of brain oscillatory activity during training and the language progression index. [Time frame: 12 weeks]
  • correlation between theta/gamma power via EEG measurements of brain oscillatory activity during training and the language progression index. [Time frame: 12 weeks]
  • correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index [Time frame: 24 weeks]
  • correlation between theta/gamma power via EEG measurements of brain oscillatory activity during training and the language progression index. [Time frame: 24 weeks]
  • correlation between theta/gamma phase-amplitude coupling via EEG measurements of brain oscillatory activity during training and the language progression index. [Time frame: 24 weeks]
  • correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index. [Time frame: 24 weeks]

Eligibility criteria

Inclusion criteria

  • aged between 3 and 6 at the time of inclusion
  • Have received a formal medical diagnosis of ASD
  • Have the consent of the parent(s)
  • Declaration of a language delay by the parents
  • Affiliated to social security or equivalent scheme

Exclusion criteria

  • Conditions likely to interfere with the EEG and make its interpretation difficult, including severe epilepsy or cerebral malformations.
  • Treatments likely to interfere with the EEG (sedatives, psychostimulants, anxiolytics, antidepressants).
  • Known hearing impairment

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07303413 · 2024-091_THETABOOST · 2025-A00707-42

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗