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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06334029
• Other study ID #: 12.2022
• Status: Recruiting
• Start date: June 22, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: IRCCS Eugenio Medea
• Contact: Gian Marco Duma, PhD
• Phone: +39 0438414248
• Email: gianmarco.duma[@]lanostrafamiglia.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2026
• Est. primary completion date: November 22, 2026
• Gender: All
• Age group: 6 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Diagnostic Test:
• Functional and structural Connectome
Reconstruction of EEG derived functional relationship between brain regions (functional connectome). Reconstruction of thickness covariance across brain regions (structural connectome)

Locations

Country	Name	City	State
Italy	IRCCS E.Medea	Conegliano	Treviso

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between the Rey Complex figure test and the regional functional alteration	The correlation between the Rey complex figure test measuring the memory efficiency and the regional functional connectivity provides a potential diagnostic tool helping the identification of the alteration of brain areas in relationship to the known impairment of memory in patients with epilepsy	once at recrutiment
Primary	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	Measuring the spread of the epileptogenic network	In the Epilepsy group the correlation between the functional and the structural connectome identify the spreading of the epileptogenic network, and therefore the intensity of the pathology, guiding the diagnostic process	once at recrutiment