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Not yet recruitingNCT07303413THETABOOSTUpdated Dec 24, 2025

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

An interventional study of EEG recording and Picture recognition test in Autism Spectrum Disorder, sponsored by Institut Pasteur. Not yet recruiting. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Institut Pasteur · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
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Study 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.

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Conditions studied

  • Autism Spectrum Disorder

Keywords

  • language
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In context

Autism Spectrum Disorder

1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.

This study's planned enrollment of 24 is below the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Institut Pasteur is the lead sponsor of 99 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    short baseline

    First baseline of 4 weeks and a second baseline of 8 weeks

    Behavioral: EEG recording · Behavioral: Picture recognition test

  • Experimental
    medium baseline

    First baseline of 6 weeks and a second baseline of 6 weeks

    Behavioral: EEG recording · Behavioral: Picture recognition test

  • Experimental
    long baseline

    First baseline of 8 weeks and a second baseline of 4 weeks

    Behavioral: EEG recording · Behavioral: Picture recognition test

Interventions

  • BehavioralEEG recording

    EEG recording while listening to natural sounds

  • BehavioralPicture 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.

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What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. Comparison of theta/gamma frequency bands via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training

    Time frame: 12 weeks

  3. Comparison of Phase Locking Value via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training

    Time frame: 12 weeks

  4. 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

  5. correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index.

    Time frame: 12 weeks

  6. correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index.

    Time frame: 12 weeks

  7. 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

  8. correlation between theta/gamma power via EEG measurements of brain oscillatory activity during training and the language progression index.

    Time frame: 12 weeks

  9. correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index

    Time frame: 24 weeks

  10. correlation between theta/gamma power via EEG measurements of brain oscillatory activity during training and the language progression index.

    Time frame: 24 weeks

  11. 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

  12. correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index.

    Time frame: 24 weeks

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07303413
Lead sponsor
Institut Pasteur
Collaborators
IHU reConnect
Responsible party
Sponsor
First posted
Dec 24, 2025
Start date
Jan 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Dec 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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