Neurodevelopmental DisordersNCT05269927
A Multi-domain Approach for the Characterization and Early Diagnosis of Neurodevelopmental Disorders
A study testing EEG, DNA samples and clinical data in people with Neurodevelopmental Disorders, run by IRCCS Eugenio Medea at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 5 to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- EEG, DNA samples and clinical data
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2016to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Neurodevelopmental Disorders
- Being tested
- EEG, DNA samples, clinical data, environmental data
- Keywords
- Neurodevelopmental disorder, EEG, Multi-domain data, Machine Learning
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDiagnostic test
resting state EEG
DNA samplesDiagnostic test
genotypings of twelve CNTNAP2 SNPs from DNA obtained by saliva samples
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).
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
| Study group | Role | What they receive |
|---|---|---|
| TD (typically developing) infants | Experimental | Typically developing infants, infants without familiar risk for ASD or LD. Receives: Diagnostic Test: EEG; Diagnostic Test: DNA samples; Diagnostic Test: clinical data; Other: environmental data |
| HR (high risk) for LD infants | Experimental | Infants at high risk for language disorders Receives: Diagnostic Test: EEG; Diagnostic Test: DNA samples; Diagnostic Test: clinical data; Other: environmental data |
| HR for ASD infants | Experimental | Infants at high risk for autism spectrum disorder Receives: Diagnostic Test: EEG; Diagnostic Test: DNA samples; Diagnostic Test: clinical data; Other: environmental data |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG power spectral density (PSD)
Power spectral density (PSD) estimated in the delta, theta, alpha, beta and gamma frequency bands of the EEG
Measured: one year after the end of the recruitment
EEG signal coherence
EEG signal coherence
Measured: 18 months after the end of the recruitment
EEG signal entropy
EEG signal entropy
Measured: 18 months after the end of the recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start1 Mar 2016
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269927
- Sponsor's protocol ID
- 707
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2022
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-domain Approach for the Characterization and Early Diagnosis of Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT05269927
- Acronym / sponsor ID
- 707
- Conditions
- Neurodevelopmental Disorders
- Keywords
- Neurodevelopmental disorder, EEG, Multi-domain data, Machine Learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TD (typically developing) infants | Experimental | Diagnostic Test: EEG, Diagnostic Test: DNA samples, Diagnostic Test: clinical data, Other: environmental dataTypically developing infants, infants without familiar risk for ASD or LD. |
| HR (high risk) for LD infants | Experimental | Diagnostic Test: EEG, Diagnostic Test: DNA samples, Diagnostic Test: clinical data, Other: environmental dataInfants at high risk for language disorders |
| HR for ASD infants | Experimental | Diagnostic Test: EEG, Diagnostic Test: DNA samples, Diagnostic Test: clinical data, Other: environmental dataInfants at high risk for autism spectrum disorder |
Who may qualify
- Ages
- 5 to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEGresting state EEG | Diagnostic test | HR (high risk) for LD infants, HR for ASD infants, TD (typically developing) infants |
| DNA samplesgenotypings of twelve CNTNAP2 SNPs from DNA obtained by saliva samples | Diagnostic test | HR (high risk) for LD infants, HR for ASD infants, TD (typically developing) infants |
| clinical datastandardized 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). | Diagnostic test | HR (high risk) for LD infants, HR for ASD infants, TD (typically developing) infants |
| environmental dataquestionnaires 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 | Other | HR (high risk) for LD infants, HR for ASD infants, TD (typically developing) infants |
Primary outcome
EEG power spectral density (PSD)
Time frame: 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 coherence
Time frame: 18 months after the end of the recruitment
EEG signal coherence
EEG signal entropy
Time frame: 18 months after the end of the recruitment
EEG signal entropy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG, DNA samples and clinical data in people with Neurodevelopmental Disorders, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG power spectral density (PSD) (time frame: one year after the end of the recruitment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2022.