Cortical Tracking of Speech in the First Year of Life

NCT07531706 | Recruiting

• 1 other identifier: 78/24
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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.

  Age 18 months

Secondary Outcomes (1)

• Global Development

  Age 18 months

Study Arms (2)

General population

Other: Electrophysiological recording; Behavioral: Behavioral Assessment

Infants at familiar risk for language and learning impairment

Other: Electrophysiological recording; Behavioral: Behavioral Assessment

Interventions

Electrophysiological recording OTHER

Investigation of early neural markers using electrophysiology at 8 months

General population; Infants at familiar risk for language and learning impairment

Behavioral Assessment BEHAVIORAL

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

General population; Infants at familiar risk for language and learning impairment

Eligibility Criteria

• Age: 30 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• Basque Center on Cognition, Brain and Language (BCBL): collaborator

Study Sites (1)

IRCCS Eugenio Medea Associazione La nostra famiglia

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

MeSH Terms

Conditions

Language Development Disorders

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start: October 14, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: IPD will be available from 18/03/2026 to the end of project (February 2028).

Locations

IT (1)