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| Name | Class |
|---|---|
| Ministry of Health, Italy | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TD (typically developing) infants | Experimental | Typically developing infants, infants without familiar risk for ASD or LD. |
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| HR (high risk) for LD infants | Experimental | Infants at high risk for language disorders |
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| HR for ASD infants | Experimental | Infants at high risk for autism spectrum disorder |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EEG | Diagnostic Test | resting state EEG |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientific Institute IRCCS E. Medea | Bosisio Parini | Lecco | 23842 | Italy |
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| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D004569 | Electroencephalography |
| ID | Term |
|---|---|
| D003943 | Diagnostic Techniques, Neurological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
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| DNA samples | Diagnostic Test | genotypings of twelve CNTNAP2 SNPs from DNA obtained by saliva samples |
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| 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). |
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| 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 |
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