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Cortical Tracking of Speech in the First Year of Life

NCT07531706 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-04-15

No results posted yet for this study

Summary

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

  • Language Development
  • Language Development Disorders
  • Infant Development
  • Infant Developmental Assessment

Interventions

OTHER

Electrophysiological recording

Investigation of early neural markers using electrophysiology at 8 months

BEHAVIORAL

Behavioral Assessment

Behavioral Assessment at 8 months with Bayley-III Scales of Infant and Toddler Development.

Sponsors & Collaborators

  • Basque Center on Cognition, Brain and Language (BCBL)

    collaborator UNKNOWN

  • IRCCS Eugenio Medea

    lead OTHER

Eligibility

Min Age
30 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2027-12-31
Completion
2028-02-29

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07531706 on ClinicalTrials.gov