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临床试验/NCT07303413
NCT07303413尚未招募不适用

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

Institut Pasteur0 个研究点目标入组 24 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
主要终点
The difference in the progression of language acquisition measured by the difference in the number of images recognised in image recognition tests.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

The difference in the progression of language acquisition measured by the difference in the number of images recognised in image recognition tests.

时间窗: 12 weeks

次要结局

  • 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)

研究者

申办方类型
Industry
责任方
Sponsor

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