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

Not Applicable

Completed

• Conditions: Neurodevelopmental Disorders

• Registration Number: NCT05269927
• Lead Sponsor: IRCCS Eugenio Medea

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2022-02
• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-25
• Last Update Submitted: 2022-02-25
• Study First Posted: 2022-03-08
• Last Update Posted: 2022-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
EEG power spectral density (PSD)	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
EEG signal entropy	18 months after the end of the recruitment	EEG signal entropy
EEG signal coherence	18 months after the end of the recruitment	EEG signal coherence

Trial Locations

Locations (1)

Scientific Institute IRCCS E. Medea; 🇮🇹 Bosisio Parini, Lecco, Italy