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

NCT06334029 | Recruiting

• 1 other identifier: 12.2022
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Identification of regional alteration in the value of functional connectivity

  By comparing the value of functional connectivity derived from the EEG, between Epilepsy and control group, it is possible to identify altered brain regions to non-invasively identify the epileptogenic area, improving the diagnostic process

  once at recrutiment

Secondary Outcomes (1)

• Measuring the spread of the epileptogenic network

  once at recrutiment

Other Outcomes (1)

• Correlation between the Rey Complex figure test and the regional functional alteration

  once at recrutiment

Study Arms (2)

Epilepsy

Recording of resting state EEG and MRI

Diagnostic Test: Functional and structural Connectome

Control group

EEG resting state data recording

Diagnostic Test: Functional and structural Connectome

Interventions

Functional and structural Connectome DIAGNOSTIC_TEST

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

Control group; Epilepsy

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with focal epilepsy with drug resistance

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS E.Medea

Conegliano, Treviso, 31015, Italy

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Gian Marco Duma, PhD

  IRCCS E. Medea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gian Marco Duma, PhD

CONTACT

+39 0438414248; gianmarco.duma@lanostrafamiglia.it

Darling Boachie

CONTACT

+39 0438 41242; segreteriascientifica.medea.veneto@lanostrafamiglia.it

Study Design

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

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: June 22, 2023
• Primary Completion (Estimated): November 22, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)