Characterization of Neurocognitive Profiles in Neurodevelopmental Disorders and Epilepsy: a Transdiagnostic Approach (DIS-Neurodev)

March 10, 2025 updated by: IRCCS Eugenio Medea

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Neurodevelopmental disorders (NDDs) are a heterogeneous group of clinically significant conditions that emerge in early childhood, leading to mild to severe impairments in personal, social, and academic functioning, negatively impacting quality of life. Up to 10% of children are diagnosed with one or more NDDs. Epilepsy is one of the most common neurological comorbidities associated with NDDs.

Traditional categorical diagnoses have shaped scientific research under the assumption that each NDD category is characterized by specific neurocognitive and biological markers. However, current classification systems struggle to explain the symptomatic overlap observed among disorders traditionally considered distinct in their etiology. In fact, comorbidity among different NDDs is more common than the exception. For instance, learning disorders are present in 44% of children with ADHD and 65-85% of autistic children, while ADHD and autism have comorbidity rates ranging from 30% to 70%. Recent neuroimaging studies have also demonstrated that structural and functional neural patterns are shared across multiple NDDs, concluding that no disorder-specific biomarkers could be identified in large patient cohorts.

These clinical findings suggest adopting an alternative transdiagnostic approach, considering NDDs in terms of dimensions rather than categories. A deeper understanding of the shared neural, behavioral, and biological mechanisms among NDDs could scientifically validate the shift from a category-based to a dimensional approach, emphasizing individual neurocognitive variability and improving therapeutic efficacy.

Aligned with the transdiagnostic paradigm, this project aims to characterize the neuropsychological and neurophysiological profiles of certain NDDs (i.e., attention-deficit/hyperactivity disorder (ADHD), autism, intellectual disability, language and learning disorders). The presence of common neurocognitive profiles across diagnostic categories will be investigated using high-density EEG in both resting-state conditions and during specific computerized cognitive tasks. Specifically, these tasks will assess the ability to flexibly adapt cognitive control (CC) to environmental demands. Cognitive control refers to the set of mental abilities required to regulate thoughts, emotions, and behavior based on external demands and internal motivational states. It includes processes such as inhibition, working memory, cognitive flexibility, and planning-executive functions that are essential for self-regulation and often impaired in many NDDs. Thus, investigating CC across different diagnostic groups is crucial for developing intervention protocols tailored to individual needs rather than categorical diagnoses.

A battery of tests and questionnaires, part of the routine neuropsychological assessment administered to all patients at the IRCCS E. Medea "La Nostra Famiglia" center, will be given to both patients and their families. Additionally, participants will complete a computerized behavioral task (Mario task) and a second computerized task while undergoing electroencephalogram (EEG) recording (Flanker task). Administering both tasks allows for understanding how predictive context modulates the ability to inhibit inappropriate actions (Mario task) and manage cognitive conflict in the presence of distractor stimuli (Flanker task). The details of the questionnaires and computerized tasks will be described in the "Experimental Protocol" section.

The integration of various computerized cognitive tasks with neurophysiological measures will enable the creation of a multidimensional profile for each participant, encompassing the evaluation of brain network flexibility and organization at rest, EEG responses to cognitive tasks, and neuropsychological assessment outcomes. A dimensionality reduction approach will be applied to the data to identify separable clusters of neurocognitive functioning, characterized not only by neural organization and neuropsychological performance but also by environmental factors (e.g., socioeconomic indicators). In this framework, the goal is not to identify population-specific neurocognitive markers but rather shared (transdiagnostic) functional profiles that can define an individual's characteristics independently of their diagnostic category.

Additionally, analyzing shared and specific profiles among individuals with NDDs with or without epilepsy and, conversely, among individuals with epilepsy with or without an NDD diagnosis, represents a powerful validation tool for behavioral and neurophysiological markers.

This project, in line with the Framework Agreement (IRCCS-University Platform) approved by the Ministry of Health on May 3, 2023 (Id MIUR 4525), involves collaboration with the Department of General Psychology at the University of Padova. This collaboration aims to apply advanced data analysis techniques to both EEG signals and behavioral data (neuropsychological assessment and tasks)

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italy/Treviso
      • Conegliano, Italy/Treviso, Italy, 31015
        • IRCC E.Medea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with diagnosis of neurodevelopmental disorders

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Participants will undergo EEG recording while performing a computer based neuropsychological task evaluating cognitive control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG amplitude variation
Time Frame: Through study completion, an average of 1 year
EEG evoked potentials amplitude measured in micronvolt
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Eugenio Medea

Collaborators

University of Padova

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1081 (Förderung, Forschung und Lehre der LMU;)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Clinical Trials on Computer based task with EEG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe