Back to resultsA Multi-domain Approach for the Characterization and Early Diagnosis of Neurodevelopmental Disorders
Primary Purpose
Neurodevelopmental Disorders
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
EEG
DNA samples
clinical data
environmental data
Sponsored by
About this trial
This is an interventional basic science trial for Neurodevelopmental Disorders focused on measuring Neurodevelopmental disorder, EEG, Multi-domain data, Machine Learning
Eligibility Criteria
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
Sites / Locations
- Scientific Institute IRCCS E. Medea
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
TD (typically developing) infants
HR (high risk) for LD infants
HR for ASD infants
Arm Description
Typically developing infants, infants without familiar risk for ASD or LD.
Infants at high risk for language disorders
Infants at high risk for autism spectrum disorder
Outcomes
Primary Outcome Measures
EEG power spectral density (PSD)
Power spectral density (PSD) estimated in the delta, theta, alpha, beta and gamma frequency bands of the EEG
EEG signal coherence
EEG signal coherence
EEG signal entropy
EEG signal entropy
Secondary Outcome Measures
Full Information
NCT ID
NCT05269927
First Posted
February 1, 2022
Last Updated
February 25, 2022
Sponsor
IRCCS Eugenio Medea
Collaborators
Ministry of Health, Italy
1. Study Identification
Unique Protocol Identification Number
NCT05269927
Brief Title
A Multi-domain Approach for the Characterization and Early Diagnosis of Neurodevelopmental Disorders
Official Title
A Multi-domain Approach for the Characterization and Early Diagnosis of Neurodevelopmental Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea
Collaborators
Ministry of Health, Italy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurodevelopmental Disorders
Keywords
Neurodevelopmental disorder, EEG, Multi-domain data, Machine Learning
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TD (typically developing) infants
Arm Type
Experimental
Arm Description
Typically developing infants, infants without familiar risk for ASD or LD.
Arm Title
HR (high risk) for LD infants
Arm Type
Experimental
Arm Description
Infants at high risk for language disorders
Arm Title
HR for ASD infants
Arm Type
Experimental
Arm Description
Infants at high risk for autism spectrum disorder
Intervention Type
Diagnostic Test
Intervention Name(s)
EEG
Intervention Description
resting state EEG
Intervention Type
Diagnostic Test
Intervention Name(s)
DNA samples
Intervention Description
genotypings of twelve CNTNAP2 SNPs from DNA obtained by saliva samples
Intervention Type
Diagnostic Test
Intervention Name(s)
clinical data
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
environmental data
Intervention Description
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 Outcome Measure Information:
Title
EEG power spectral density (PSD)
Description
Power spectral density (PSD) estimated in the delta, theta, alpha, beta and gamma frequency bands of the EEG
Time Frame
one year after the end of the recruitment
Title
EEG signal coherence
Description
EEG signal coherence
Time Frame
18 months after the end of the recruitment
Title
EEG signal entropy
Description
EEG signal entropy
Time Frame
18 months after the end of the recruitment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Months
Maximum Age & Unit of Time
7 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Scientific Institute IRCCS E. Medea
City
Bosisio Parini
State/Province
Lecco
ZIP/Postal Code
23842
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
A Multi-domain Approach for the Characterization and Early Diagnosis of Neurodevelopmental Disorders
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