NCT05269927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

5.3 years

First QC Date

February 1, 2022

Last Update Submit

February 25, 2022

Conditions

Neurodevelopmental Disorders

Keywords

Neurodevelopmental disorderEEGMulti-domain dataMachine Learning

Outcome Measures

Primary Outcomes (3)

  • 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

  • EEG signal coherence

    EEG signal coherence

    18 months after the end of the recruitment

  • EEG signal entropy

    EEG signal entropy

    18 months after the end of the recruitment

Study Arms (3)

TD (typically developing) infants

EXPERIMENTAL

Typically developing infants, infants without familiar risk for ASD or LD.

Diagnostic Test: EEGDiagnostic Test: DNA samplesDiagnostic Test: clinical dataOther: environmental data

HR (high risk) for LD infants

EXPERIMENTAL

Infants at high risk for language disorders

Diagnostic Test: EEGDiagnostic Test: DNA samplesDiagnostic Test: clinical dataOther: environmental data

HR for ASD infants

EXPERIMENTAL

Infants at high risk for autism spectrum disorder

Diagnostic Test: EEGDiagnostic Test: DNA samplesDiagnostic Test: clinical dataOther: environmental data

Interventions

EEGDIAGNOSTIC_TEST

resting state EEG

HR (high risk) for LD infantsHR for ASD infantsTD (typically developing) infants
DNA samplesDIAGNOSTIC_TEST

genotypings of twelve CNTNAP2 SNPs from DNA obtained by saliva samples

HR (high risk) for LD infantsHR for ASD infantsTD (typically developing) infants
clinical dataDIAGNOSTIC_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).

HR (high risk) for LD infantsHR for ASD infantsTD (typically developing) infants
environmental dataOTHER

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

HR (high risk) for LD infantsHR for ASD infantsTD (typically developing) infants

Eligibility Criteria

Age5 Months - 7 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scientific Institute IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2022

First Posted

March 8, 2022

Study Start

March 1, 2016

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

March 8, 2022

Record last verified: 2022-02

Locations

IT(1)