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OpenTrials
Completed

NCT Number: NCT05269927

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

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.

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Key information

Conditions

Neurodevelopmental Disorders Mental Disorders

Age range

5 month–7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scientific Institute IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • APGAR scores at birth at 1' and 5' > 7;
  • newborn screening otoacoustic emissions in the norm;
  • absence of neurological disorders;
  • Italian as the language mainly spoken in the family nucleus.

Exclusion criteria

  • APGAR scores at birth at 1' and 5' <= 7;
  • newborn screening otoacoustic emissions not in the norm;
  • presence of neurological disorders;
  • non-Italian native speaker

Treatment and study plan

EEG

Diagnostic Test

resting state EEG

DNA samples

Diagnostic Test

genotypings of twelve CNTNAP2 SNPs from DNA obtained by saliva samples

clinical data

Diagnostic Test

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).

environmental data

Other

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

Primary outcomes

  1. EEG power spectral density (PSD)

    Time frame: one year after the end of the recruitment

    Power spectral density (PSD) estimated in the delta, theta, alpha, beta and gamma frequency bands of the EEG

  2. EEG signal coherence

    Time frame: 18 months after the end of the recruitment

    EEG signal coherence

  3. EEG signal entropy

    Time frame: 18 months after the end of the recruitment

    EEG signal entropy

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Collaborators

  • Ministry of Health, Italy

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 8, 2022
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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