Clinical trial NCT06334029: Observational Study of the Structural-functional Connectome in Patients With Epilepsy
Official title: Observational Study of the Structural-functional Connectome in Patients With Epilepsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with focal epilepsy with drug resistance

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.


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.

Primary outcomes:
measure: Identification of regional alteration in the value of functional connectivity
timeFrame: once at recrutiment
Secondary outcomes:
measure: Measuring the spread of the epileptogenic network
timeFrame: once at recrutiment
Other outcomes:
measure: Correlation between the Rey Complex figure test and the regional functional alteration
timeFrame: once at recrutiment
Locations:
city: Conegliano
country: Italy
facility: IRCCS E.Medea
state: Treviso
Study officials:
affiliation: IRCCS E. Medea
name: Gian Marco Duma, PhD
role: PRINCIPAL_INVESTIGATOR
References: