Observational Study of the Structural-functional Connectome in Patients With Epilepsy

NCT ID: NCT06334029

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-22
• Study Completion Date: 2026-12-31

Brief Summary

Over the past decade, the concept of the brain as a complex network has extremely influenced the way regarding how the latter is studied (Bartolomei et al., 2017). The structure of both structural and functional networks within the brain has been related to optimal brain functioning (Duma et al., 2022). This evolution of methods and approaches of investigation has directly impacted the study of epilepsy. An early conception of focal epilepsy was that it was related to the activity of the epileptogenic zone, which was identified as the generative element of seizures. However, what was previously considered focal was found to be network alterations at various levels, thus moving from the epileptogenic zone to the concept of the epileptogenic network. Alterations in both the structural and functional network, compared with a healthy control population, have been identified in various forms of epilepsy from focal to idiopathic generalized epilepsy (Lariviere et al., 2022, Zhang et al., 2009). Often the identification and removal of the epileptogenic network, turns out to be the elective therapy in drug-resistant focal epilepsies. The process of diagnosing and defining the epileptogenic network is still debated today. One of the most widely used methods is the implantation of intracranial electrodes for electroencephalographic recording of seizures (Bartolomei et al., 2017). This methodology carries with it several, albeit controlled, risks to the patient. New noninvasive approaches are being developed seeking to integrate information from structural neuroimaging and cortical electrical activity measured by high-density electroencephalography with external electrodes (Duma et al., 2021). These new approaches also include simulative approaches that exploit individualized information such as cortex geometry and patient-specific white matter connections (Courtiol et al. 2020). Thus, starting from a simple structural and diffusion MRI, which is done in routine clinical examinations, multiple localizing hypotheses of the epileptogenic network can be tested using simulative models and then compared with the real EEG signal as validation. Of great relevance is also to understand how the structural-functional connectome relates to cognitive function in patients with epilepsy, who have a high probability of presenting impaired functioning in one or more cognitive domains.

Conditions

Epilepsy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Epilepsy

Recording of resting state EEG and MRI

Functional and structural Connectome

Intervention Type: DIAGNOSTIC_TEST

Reconstruction of EEG derived functional relationship between brain regions (functional connectome). Reconstruction of thickness covariance across brain regions (structural connectome)

Control group

EEG resting state data recording

Functional and structural Connectome

Intervention Type: DIAGNOSTIC_TEST

Reconstruction of EEG derived functional relationship between brain regions (functional connectome). Reconstruction of thickness covariance across brain regions (structural connectome)

Interventions

Functional and structural Connectome

Reconstruction of EEG derived functional relationship between brain regions (functional connectome). Reconstruction of thickness covariance across brain regions (structural connectome)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• a diagnosis of focal or generalized epilepsy confirmed by specialist evaluation;
• at least one MRI scan of the brain that includes T1w
• at least one recording with resting state EEG
• age between 6 and 65 years at the time of the evaluation of the present study;
• ability to take part in a neuropsychological assessment.

Exclusion Criteria

• vascular causes or non-low grade tumors as causes of epilepsy
• age different from the range 6-65 years
• neuroradiologic examination not complete
• absence of resting state recording
• inability to take part in a neuropsychological evaluation.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Eugenio Medea

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gian Marco Duma, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS E. Medea

Locations

IRCCS E.Medea

Conegliano, Treviso, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gian Marco Duma, PhD

Role: CONTACT

gianmarco.duma@lanostrafamiglia.it

+39 0438414248

Darling Boachie

Role: CONTACT

segreteriascientifica.medea.veneto@lanostrafamiglia.it

+39 0438 41242

Facility Contacts

Duma Gian Marco, PhD

Role: primary

gianmarco.duma@lanostrafamiglia.it

+39 0438414248

Other Identifiers

12.2022

Identifier Type: -

Identifier Source: org_study_id