Actively Recruiting

Age: 6Months - 8Years
All Genders
Healthy Volunteers
ID05767242

Early Neurophysiological Markers of Language Impairments: a Longitudinal Study on Infants At Familial Risk

Led by IRCCS Eugenio Medea · Updated on 2025-02-05

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to identify very early brain activity markers that may indicate risk for language impairments in children. It focuses on tracking developmental learning patterns in infants who have a family history of language difficulties. The study follows children from infancy through school age to understand how early neurophysiological processes relate to later reading and spelling abilities. Participants undergo electrophysiological recordings at 6, 12, and 24 months to capture early neural markers. Later, individual behavioral assessments are conducted at ages 3, 4.5, 6, and 8 years to evaluate language-related skills and development. The study includes infants from the Medea BabyLab cohort, with groups based on familial risk for language impairments. During the study, children are assessed on various language and cognitive skills including vocabulary, phonological awareness, memory, syntactic and lexical comprehension, letter knowledge, reading, and spelling at specific ages. Researchers also measure secondary outcomes like naming accuracy and visual-motor integration. The study monitors these developmental trajectories over several years to build a prognostic model predicting language outcomes based on early brain activity.

CONDITIONS

Brief Title

Early Neurophysiological Markers of Language Impairments

Who Can Participate

Age: 6Months - 8Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy infants aged less than 24 months
  • Infants with or without familial risk for language impairments (at least one first-degree relative with a clinical diagnosis of language impairment or learning disability)
  • Both parents are native Italian speakers
Not Eligible

You will not qualify if you...

  • Gestational age less than 37 weeks and/or birth weight less than 2500 grams
  • APGAR scores at birth less than 7 at 1 and 5 minutes
  • Bayley Cognitive Score less than 7
  • Certified diagnosis of intellectual deficiency, attention-deficit disorder, sensorial or neurological disorders, or autism in a first-degree relative

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - From 6 to 24 months of age

Participants undergo electrophysiological recordings to investigate early neural markers at 6, 12, and 24 months.

3 visits (in-person) at 6, 12, and 24 months

Long-term Monitoring

Duration - From 3 to 8 years of age

Participants receive individual behavioral assessments assessing language and cognitive development at later ages.

4 visits (in-person) at ages 3, 4.5, 6, and 8 years

Trial Site Locations

Total: 1 location

1

Associazione La Nostra Famiglia - IRCCS Eugenio Medea

Bosisio Parini, LC, Italy, 23842

Actively Recruiting

Loading map...

Research Team

C

Chiara Cantiani, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Similar Trials

A Developmental Framework For Linking Phonological And Morph...

Developmental Language Disorder

Actively Recruiting

2 locations

Brain Organization, Development, and Response to Interventio...

Development, Infant

Actively Recruiting

2 locations

Improving the Retention of Speech-Perceptual Learning in Adu...

Developmental Language Disorder

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here