Characterization of Neurocognitive Profiles in Neurodevelopmental Disorders and Epilepsy: a Transdiagnostic Approach

NCT06877260 | Active Not Recruiting DMC

• 1 other identifier: 1081
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Neurodevelopmental disorders (NDDs) are early-onset conditions affecting personal, social, and academic functioning, with high comorbidity rates and shared neurobiological traits. Traditional diagnostic categories struggle to explain symptom overlap, supporting a transdiagnostic approach that views NDDs as dimensions rather than distinct entities. This project aims to identify common neuropsychological and neurophysiological profiles in ADHD, autism, intellectual disability, and learning disorders using high-density EEG and cognitive tasks assessing cognitive control. By integrating neuropsychological assessments, EEG responses, and behavioral data, the study seeks to identify shared functional profiles rather than disorder-specific biomarkers. Additionally, it will analyze the relationship between NDDs and epilepsy to validate behavioral and neurophysiological markers. Conducted in collaboration with the University of Padua, the study employs advanced data analysis to enhance personalized interventions.

Conditions

Neurodevelopmental Disorder (Diagnosis); Epilepsy

Keywords

transdiagnostic approach; neural fingerprint; neurodevelopmental disorders

Outcome Measures

Primary Outcomes (1)

• EEG amplitude variation

  EEG evoked potentials amplitude measured in micronvolt

  Through study completion, an average of 1 year

Study Arms (1)

Neuropsychological EEG testing

Patients will undergo an EEG and neuropsycholgical tasks evaluation, as well as the control group

Diagnostic Test: Computer based task with EEG

Interventions

Computer based task with EEG DIAGNOSTIC_TEST

Participants will undergo EEG recording while performing a computer based neuropsychological task evaluating cognitive control

Neuropsychological EEG testing

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients with diagnosis of neurodevelopmental disorders

You may qualify if:

• Age between 6 and 16 years at the time of the study assessment.
• Participant's ability to collaborate in performing computerized cognitive tasks.
• Ability to undergo a neuropsychological assessment in the Italian language

You may not qualify if:

• Presence of organic disorders such as previous ischemic events, cerebral neoplastic elements, or a clinical history including brain surgery.
• Age outside the 6-16 years range.
• Inability to perform computerized cognitive tasks.
• Inability to undergo a neuropsychological assessment in the Italian language.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• University of Padova: collaborator

Study Sites (1)

IRCC E.Medea

Conegliano, Italy/Treviso, 31015, Italy

Location

Related Publications (4)

• Duma GM, Di Bono MG, Mento G. Grounding Adaptive Cognitive Control in the Intrinsic, Functional Brain Organization: An HD-EEG Resting State Investigation. Brain Sci. 2021 Nov 15;11(11):1513. doi: 10.3390/brainsci11111513.

  PMID: 34827511 BACKGROUND

• Dalgleish T, Black M, Johnston D, Bevan A. Transdiagnostic approaches to mental health problems: Current status and future directions. J Consult Clin Psychol. 2020 Mar;88(3):179-195. doi: 10.1037/ccp0000482.

  PMID: 32068421 BACKGROUND

• Joshi G, Faraone SV, Wozniak J, Tarko L, Fried R, Galdo M, Furtak SL, Biederman J. Symptom Profile of ADHD in Youth With High-Functioning Autism Spectrum Disorder: A Comparative Study in Psychiatrically Referred Populations. J Atten Disord. 2017 Aug;21(10):846-855. doi: 10.1177/1087054714543368. Epub 2014 Aug 1.

  PMID: 25085653 BACKGROUND

• Astle DE, Holmes J, Kievit R, Gathercole SE. Annual Research Review: The transdiagnostic revolution in neurodevelopmental disorders. J Child Psychol Psychiatry. 2022 Apr;63(4):397-417. doi: 10.1111/jcpp.13481. Epub 2021 Jul 23.

  PMID: 34296774 BACKGROUND

MeSH Terms

Conditions

Neurodevelopmental Disorders; Disease; Epilepsy

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 14, 2025
• Study Start: November 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)