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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07303413
Acronym
THETABOOST
Enrollment
24
Registered
2025-12-24
Start date
2026-01-31
Completion date
2027-09-30
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

language

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.

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.

Sponsors

IHU reConnect
CollaboratorUNKNOWN
Institut Pasteur
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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
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 training12 weeks
correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index.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 training12 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 index24 weeks
Comparison of Phase Locking Value via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training12 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026