Language DevelopmentNCT07531706
Cortical Tracking of Speech in the First Year of Life
An observational study of Language Development and Language Development Disorders, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 34 weeksHealthy volunteers can take part
- Conditions the study is for
- Language Development, Language Development Disorders, Infant Development
- What is being tested?
- Electrophysiological recording and Behavioral Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2025to Feb 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 34 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants will be recruited from general population in Lombardia (Italy).
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Eugenio Medea Associazione La nostra famiglia
Bosisio Parini, Lecco, 23842
Chiara Cantiani, 031-877924, chiara.cantiani@lanostrafamiglia.it
About this study
Official title: 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:
Read more
- 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
- Being tested
- Electrophysiological recording, Behavioral Assessment
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrophysiological recordingOther
Investigation of early neural markers using electrophysiology at 8 months
Behavioral AssessmentBehavioural
Behavioral Assessment at 8 months with Bayley-III Scales of Infant and Toddler Development.
| Study group | Role | What they receive |
|---|---|---|
| General population | Not described Receives: Other: Electrophysiological recording; Behavioral: Behavioral Assessment | |
| Infants at familiar risk for language and learning impairment | Not described Receives: Other: Electrophysiological recording; Behavioral: Behavioral Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Age 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start14 Oct 2025
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- Basque Center on Cognition, Brain and Language (BCBL)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531706
- Sponsor's protocol ID
- 78/24
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2026
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.