Cortical Tracking of Speech in the First Year of Life

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

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.

Study Overview

• Status: Recruiting
• Conditions: Language Development Disorders; Infant Development; Language Development; Infant Developmental Assessment
• Intervention / Treatment: Other: Electrophysiological recording; Behavioral: Behavioral Assessment

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• Italy
  • Lecco
    • Bosisio Parini, Lecco, Italy, 23842
      • Recruiting
      • IRCCS Eugenio Medea Associazione La nostra famiglia
      • Contact: Chiara Cantiani; Phone Number: 031-877924; Email: chiara.cantiani@lanostrafamiglia.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
General population	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.
Infants at familiar risk for language and learning impairment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Age 18 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Language Development Disorders; Behavioral Disciplines and Activities; Psychological Tests; Neuropsychological Tests
• Other Study ID Numbers: 78/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: EEG recordings at age 8 months and behavioral assessment data will be shared with researchers at Basque Center on Cognition, Brain and Language (BCBL) for data analysis purposes. The BCBL team will be involved in the project for stimuli creation, data analysis, and data comparison.
• IPD Sharing Time Frame: IPD will be available from 18/03/2026 to the end of project (February 2028).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE