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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Tracking of Speech in the First Year of Life: a Window Into (a)Typical Language Acquisition
- ClinicalTrials.gov ID
- NCT07531706
- Acronym / sponsor ID
- 78/24
- Conditions
- Language Development, Language Development Disorders, Infant Development, Infant Developmental Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- Basque Center on Cognition, Brain and Language (BCBL)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General population | – | Other: Electrophysiological recording, Behavioral: Behavioral Assessment |
| Infants at familiar risk for language and learning impairment | – | Other: Electrophysiological recording, Behavioral: Behavioral Assessment |
Who may qualify
- Ages
- 30 to 34 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants will be recruited from general population in Lombardia (Italy).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrophysiological recordingInvestigation of early neural markers using electrophysiology at 8 months | Other | General population, Infants at familiar risk for language and learning impairment |
| Behavioral AssessmentBehavioral Assessment at 8 months with Bayley-III Scales of Infant and Toddler Development. | Behavioural | General population, Infants at familiar risk for language and learning impairment |
Primary outcome
Communicative Development
Time frame: Age 18 months
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.
1 secondary outcome
Global Development
Time frame: Age 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: 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.
Related trials for Language Development
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
Enrolling by invitation
Brain Stimulation Paired With Structured Language Learning in Adults
Language Development, Learning
Recruiting
Personalization of Visual Characters and Text-to-Speech (TTS) to Support Learning in Students With Reading Difficulties
Developmental Dyslexia, Reading Problem
Recruiting
Dynamic Assessment of the Risk for Language and Reading Disorders in Monolingual and Multilingual Children
Developmental Dyslexia, Developmental Language Disorder
Not yet recruiting
Trial of Center-Based Early Start Denver Model vs. Pivotal Response Treatment in Children With Autism
Autism Spectrum Disorder (ASD), Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
IRCCS Eugenio Medea Associazione La nostra famiglia
Bosisio Parini, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Language Development and Language Development Disorders, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Communicative Development (time frame: Age 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.