跳至主要内容
临床试验/NCT07531706
NCT07531706招募中不适用

Cortical Tracking of Speech in the First Year of Life: a Window Into (a)Typical Language Acquisition

IRCCS Eugenio Medea1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年10月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Communicative Development

研究概览

简要总结

The goal of this observational study is to investigate early neural mechanisms underlying the processing of spoken language, specifically the phenomenon of cortical tracking, and to determine whether these mechanisms can serve as early predictors of later language development outcomes in infants, including both typical and atypical trajectories.

The main questions it aims to answer are:

  • How do infants with and without a familial history of language and learning impairments differ in their neural ability to track speech and non-speech auditory stimuli at an early stage of development (around 8 months of age)?
  • To what extent do early cortical tracking mechanisms predict later language abilities, including both receptive and expressive skills, measured at approximately 18 months of age? Researchers will compare infants with a familial risk for language and learning impairments (FH+) to infants without such risk (FH-) to determine whether differences in early neural processing of auditory stimuli are associated with later language outcomes.

Participants will:

  • undergo a neurophysiological assessment involving non-invasive electroencephalographic (EEG) recording while being exposed to auditory stimuli, including: speech stimuli (pre-recorded simple stories in Italian, presented in infant-directed speech); non-speech stimuli (musical sounds matched for rhythmic and acoustic properties)
  • take part in a developmental assessment at approximately 8 months of age, including standardized measures of cognitive and early linguistic abilities
  • be involved in a follow-up assessment approximately 10 months later (around 18 months of age), during which standardized tests will evaluate language comprehension and production abilities
  • have additional background information collected, including family history of language and learning disorders and socio-demographic characteristics, to better understand potential risk and protective factors The study follows a longitudinal design and uses non-invasive procedures that do not require active responses from the infant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Weeks 至 34 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy infants aged between 7 and 8 months
  • Infants with and without familial risk for language disorders (Infants are assigned to the group with familial risk for language disorders if at least one first-degree relative had a certified (clinical) diagnosis of language and/or learning disorders).
  • Both parents are native-Italian speakers

排除标准

  • Gestational age < 37 weeks and/or birth-weight < 2500 grams
  • APGAR scores at birth at 1' and 5' < 7
  • Bayley Cognitive Score < 7
  • Presence of certified diagnosis of intellectual deficiency, attention-deficit disorder, sensorial and neurological disorders or autism within first-degree relatives.

研究组 & 干预措施

General population

干预措施: Electrophysiological recording (Other)

General population

干预措施: Behavioral Assessment (Behavioral)

Infants at familiar risk for language and learning impairment

干预措施: Electrophysiological recording (Other)

Infants at familiar risk for language and learning impairment

干预措施: Behavioral Assessment (Behavioral)

结局指标

主要结局

Communicative Development

时间窗: Age 18 months

Standardized score in the McArthur-Bates's CDI: Words and Gestures (Infant form) adapted by Caselli et al. (2007). Percentile scores are employed to assess gestures, receptive, and expressive vocabulary. Higher scores signify better performance.

次要结局

  • Global Development(Age 18 months)

研究者

发起方
IRCCS Eugenio Medea
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Cortical Tracking of Speech in the First Year of Life | 临床试验