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Clinical Trials/NCT07303413
NCT07303413Not yet recruitingNot Applicable

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

Institut Pasteur0 sites24 target enrollmentStarted: January 1, 2026Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
24
Primary Endpoint
The difference in the progression of language acquisition measured by the difference in the number of images recognised in image recognition tests.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
3 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 Outcomes

  • correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index.(12 weeks)
  • correlation between theta/gamma phase-amplitude coupling via EEG measurements of brain oscillatory activity during training and the language progression index.(12 weeks)
  • correlation between theta/gamma power via EEG measurements of brain oscillatory activity during training and the language progression index.(12 weeks)
  • Comparison of Neural tracking of speech via EEG measurements of brain oscillatory activity before and after a session of listening to rhythmic sound.(12 weeks)
  • Comparison of theta/gamma frequency bands via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training(12 weeks)
  • Comparison of Phase Locking Value via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training(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(12 weeks)
  • correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index.(12 weeks)
  • correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index.(24 weeks)
  • correlation between theta/gamma phase-amplitude coupling via EEG measurements of brain oscillatory activity during training and the language progression index.(24 weeks)
  • correlation between theta/gamma power via EEG measurements of brain oscillatory activity during training and the language progression index.(24 weeks)
  • correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index(24 weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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