Cortical Tracking of Speech in the First Year of Life

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-34
SponsorIRCCS Eugenio Medea

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Participants will be recruited from general population in Lombardia (Italy).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Electrophysiological recording

    Other intervention

    Investigation of early neural markers using electrophysiology at 8 months

  • Behavioral Assessment

    Behavioral

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: General population2 interventions
Group B: Infants at familiar risk for language and learning impairment2 interventions

Trial outcomes

Primary outcomes

1

Communicative Development

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.

Time frame
Age 18 months

Secondary outcomes

1

Global Development

Global development assessed with Bayley Scales of Infant and Toddler Development. Scaled scores by age (Mean = 10, Standard Deviation = 3) are computed. Higher scores mean better performance.

Time frame
Age 18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Eugenio Medea

Lead sponsor

Basque Center on Cognition, Brain and Language (BCBL)

Collaborator