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

I

IRCCS Eugenio Medea

Status

Enrolling

Conditions

Epilepsy

Treatments

Diagnostic Test: Functional and structural Connectome

Study type

Observational

Funder types

Other

Identifiers

NCT06334029
12.2022

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

6 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

150 participants in 2 patient groups

Epilepsy
Description:
Recording of resting state EEG and MRI
Treatment:
Diagnostic Test: Functional and structural Connectome
Control group
Description:
EEG resting state data recording
Treatment:
Diagnostic Test: Functional and structural Connectome

Trial contacts and locations

1

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Central trial contact

Darling Boachie; Gian Marco Duma, PhD

Data sourced from clinicaltrials.gov

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