Actively Recruiting

Age: 30Weeks - 34Weeks
All Genders
Healthy Volunteers
NCT07531706

Cortical Tracking of Speech in the First Year of Life

Led by IRCCS Eugenio Medea · Updated on 2026-04-15

50

Participants Needed

1

Research Sites

120 weeks

Total Duration

On this page

Sponsors

I

IRCCS Eugenio Medea

Lead Sponsor

B

Basque Center on Cognition, Brain and Language (BCBL)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cortical Tracking of Speech in the First Year of Life

Who Can Participate

Age: 30Weeks - 34Weeks
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy infants aged between 7 and 8 months
  • Infants with or without familial risk for language disorders (defined by at least one first-degree relative with a certified diagnosis of language and/or learning disorders)
  • Both parents are native Italian speakers
Not Eligible

You will not qualify if you...

  • Gestational age less than 37 weeks and/or birth weight less than 2500 grams
  • APGAR scores at 1 and 5 minutes less than 7
  • Bayley Cognitive Score less than 7
  • Certified diagnosis of intellectual deficiency, attention-deficit disorder, sensory or neurological disorders, or autism in first-degree relatives

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS Eugenio Medea Associazione La nostra famiglia

Bosisio Parini, Lecco, Italy, 23842

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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