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EpilepsyNCT06334029

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

An observational study of Epilepsy, run by IRCCS Eugenio Medea at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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). Read more about this study

Who is it for?
Ages 6 to 65 years
Conditions the study is for
Epilepsy
What is being tested?
Functional and structural Connectome
How many people
150 participants
Where
1 siteItaly
Study dates
22 Jun 2023to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 65 years
  • All sexes
  • Child, Adult, Older adult

Study population: Patients with focal epilepsy with drug resistance

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting
  • IRCCS E.Medea

    Conegliano, Treviso, 31015

    Duma Gian Marco, PhD, +39 0438414248, gianmarco.duma@lanostrafamiglia.it

    Recruiting

Other trials in Italy

About this study

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
Being tested
Functional and structural Connectome
Medical subject headings
Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional and structural ConnectomeDiagnostic test

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

Study groups in NCT06334029
Study groupRoleWhat they receive
EpilepsyRecording of resting state EEG and MRI
Receives: Diagnostic Test: Functional and structural Connectome
Control groupEEG resting state data recording
Receives: Diagnostic Test: Functional and structural Connectome

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: once at recrutiment

Secondary outcomes (1)
  1. 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

    Measured: once at recrutiment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2024
  2. Study start22 Jun 2023
  3. Primary completion22 Nov 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06334029
Sponsor's protocol ID
12.2022
Status last verified
Mar 2024
First submitted
20 Mar 2024
Last updated
27 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy, run by IRCCS Eugenio Medea at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gian Marco Duma, PhD (+39 0438414248, gianmarco.duma@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of regional alteration in the value of functional connectivity (time frame: once at recrutiment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.

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