Approche Rythmique et Auditive Chez Les Enfants Avec Troubles du Spectre de l'Autisme (TSA)
| Registry | NCT07303413, acronym THETABOOST |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, sequential, masking: double, supportive care |
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| Enrollment | 24 (Estimated) |
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| Sponsor | Institut Pasteur (Industry); collaborators: IHU reConnect |
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| Conditions | Autism Spectrum Disorder |
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| Interventions | EEG recording, Picture recognition test (Behavioral) |
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| Dates | start 2026-01-01 (estimated), primary completion 2027-09-01 (estimated), completion 2027-09-01 (estimated), first posted 2025-12-24, last updated 2025-12-24 |
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Related Papers Related Patents Related Grants Related Experts
All trials for Autism Spectrum Disorder All trials of EEG recording All trials of Picture recognition test
-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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+Arms and interventions
| Arm | Type | Interventions | Description |
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| short baseline | Experimental | Behavioral: EEG recording; Behavioral: Picture recognition test | First baseline of 4 weeks and a second baseline of 8 weeks |
| medium baseline | Experimental | Behavioral: EEG recording; Behavioral: Picture recognition test | First baseline of 6 weeks and a second baseline of 6 weeks |
| long baseline | Experimental | Behavioral: EEG recording; Behavioral: Picture recognition test | First baseline of 8 weeks and a second baseline of 4 weeks |
- EEG recording (Behavioral): EEG recording while listening to natural sounds
- Picture recognition test (Behavioral): 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.
+Outcome measures
Primary outcomes
- The difference in the progression of language acquisition measured by the difference in the number of images recognised in image recognition tests. [12 weeks]
Secondary outcomes
- 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. [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]
- correlation between Neural tracking 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 theta/gamma phase-amplitude coupling via EEG measurements of brain oscillatory activity during training and the language progression index. [24 weeks]
- correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index. [24 weeks]
+Eligibility
Sex: All, ages: 3 Years to 6 Years
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