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.
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
- Recruiting
IRCCS E.Medea
Conegliano, Treviso, 31015
Duma Gian Marco, PhD, +39 0438414248, gianmarco.duma@lanostrafamiglia.it
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 group | Role | What they receive |
|---|---|---|
| Epilepsy | Recording of resting state EEG and MRI Receives: Diagnostic Test: Functional and structural Connectome | |
| Control group | EEG 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.
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)
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.
- First posted27 Mar 2024
- Study start22 Jun 2023
- Primary completion22 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gian Marco Duma, PhD, Principal investigator, IRCCS E. Medea
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Structural-functional Connectome in Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT06334029
- Acronym / sponsor ID
- 12.2022
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 22 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epilepsy | – | Diagnostic Test: Functional and structural ConnectomeRecording of resting state EEG and MRI |
| Control group | – | Diagnostic Test: Functional and structural ConnectomeEEG resting state data recording |
Who may qualify
- Ages
- 6 to 65 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with focal epilepsy with drug resistance
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional and structural ConnectomeReconstruction of EEG derived functional relationship between brain regions (functional connectome). Reconstruction of thickness covariance across brain regions (structural connectome) | Diagnostic test | Control group, Epilepsy |
Primary outcome
Identification of regional alteration in the value of functional connectivity
Time frame: once at recrutiment
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
1 secondary outcome
Measuring the spread of the epileptogenic network
Time frame: once at recrutiment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gian Marco Duma, PhD principal investigator
IRCCS E. Medea
1 site in 1 country: see every site and its status.
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.