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

Neurodevelopmental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05269927
• Other study ID #: 707
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: May 31, 2021

Study information

• Verified date: February 2022
• Source: IRCCS Eugenio Medea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Months to 7 Months

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Neurodevelopmental Disorders

Intervention

Diagnostic Test:
• EEG
resting state EEG
• DNA samples
genotypings of twelve CNTNAP2 SNPs from DNA obtained by saliva samples
• 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

Locations

Country	Name	City	State
Italy	Scientific Institute IRCCS E. Medea	Bosisio Parini	Lecco

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea	Ministry of Health, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG power spectral density (PSD)	Power spectral density (PSD) estimated in the delta, theta, alpha, beta and gamma frequency bands of the EEG	one year after the end of the recruitment
Primary	EEG signal coherence	EEG signal coherence	18 months after the end of the recruitment
Primary	EEG signal entropy	EEG signal entropy	18 months after the end of the recruitment