Cortical Tracking of Speech in the First Year of Life

Официальное название

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

Обзор

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.

Вмешательства

• Другое Electrophysiological recording
  Investigation of early neural markers using electrophysiology at 8 months
• Поведенческое Behavioral Assessment
  Behavioral Assessment at 8 months with Bayley-III Scales of Infant and Toddler Development.

Первичные конечные точки

• Communicative Development [Срок оценки: Age 18 months]

Вторичные конечные точки (1)

• Global Development [Срок оценки: Age 18 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• IRCCS Eugenio Medea Associazione La nostra famiglia — Bosisio Parini

Идентификаторы

NCT: NCT07531706 · 78/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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