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A Multi-domain Approach for the Characterization and Early Diagnosis of Neurodevelopmental Disorders

NCT05269927 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-03-08

No results posted yet for this study

Summary

Diagnosis and characterization of neurodevelopmental disorders are considered challenging processes because of their complexity, multi-factoriality and heterogeneity. The present project will consider two of the most common neurodevelopmental disorders (i.e. autism spectrum disorders (ASD) and language disorders (LD)), with the aim to overcome these difficulties, by: a) deeply investigating their neuronal correlates; b) identifying multi-domain biomarkers (electrophysiological, genetic, environmental and clinical); c) developing a machine learning algorithm for early diagnosis. To achieve the above mentioned aims a multi-domain dataset will be used, comprising data collected from typically developing infants, infants at high risk for ASD and infants at high risk for LD. The data that will be used have been already collected within other trials performed at the Scientific Institute E. Medea.

Conditions

  • Neurodevelopmental Disorders

Interventions

DIAGNOSTIC_TEST

EEG

resting state EEG

DIAGNOSTIC_TEST

DNA samples

genotypings of twelve CNTNAP2 SNPs from DNA obtained by saliva samples

DIAGNOSTIC_TEST

clinical data

standardized scales measuring the infants' cognitive, motor and linguistic development administered at 6, 12 and 18. Measures available at 6 and 12 months: a) Bayley Scales of Infant and Toddler Development- Third Edition; b) Griffiths mental development scales (0-2) (GMDS-R); Measures available at 18 months: c) Language Development Survey (LDS); d) "Il PRIMO VOCABOLARIO DEL BAMBINO" (PVB); e) CHILD BEHAVIOR CHECKLIST (CBCL); (f) Modified Checklist for Autism in Toddlers (M-CHAT).

OTHER

environmental data

questionnaires administered to parents related to the following environmental factors: a) information about the presence of a clinical diagnosis of neurodevelopmental disorders within first-degree relatives; b) gestational age; c) birth weight; d) parental age and education; e) socio-economic status

Sponsors & Collaborators

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • IRCCS Eugenio Medea

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
7 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-01
Primary Completion
2021-05-31
Completion
2021-05-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05269927 on ClinicalTrials.gov