Epilepsies, PartialNCT05015868
Contribution of Genetics, Non-invasive Methods and Neuropsychology in Focal Cryptogenic Epilepsies
A study testing Functional magnetic resonance imaging-Electroencephalogram combined analysis and High density- electroencephalogram or 7 Tesla magnetic resonance imaging in people with Epilepsies, Partial and Epilepsy Intractable, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
Patients with cryptogenic focal epilepsy (unknown cause) represent about the 30% of the entire population of epilepsy patients. Among them, about 30% are drug-resistant. The implementation of of high-field magnetic resonance imaging resolution, the new Next Generation Sequencing techniques,and innovative non-invasive… Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Epilepsies, Partial, Epilepsy Intractable
- What is being tested?
- Functional magnetic resonance imaging-Electroencephalogram combined analysis and High density- electroencephalogram or 7 Tesla magnetic resonance imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- focal epilepsy, onset during pediatric age (<18 y)
- drug resistance
- unknown cause
- Brain magnetic resonance imaging negative
Who cannot join
- epilepsy with good therapeutic control
- focal symptomatic epilepsy
- age limits onset (> 18 y)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Scientific Institute IRCCS Eugenio Medea
Bosisio Parini, lecco, 23842
About this study
Official title: Contribution of Genetics, Non-invasive Neurophysiological Methods, Neuroimaging and Neuropsychology in Identifying the Cause and the Epileptogenic Zone in Focal Cryptogenic Epilepsies
Patients with cryptogenic focal epilepsy (unknown cause) represent about the 30% of the entire population of epilepsy patients. Among them, about 30% are drug-resistant. The implementation of of high-field magnetic resonance imaging resolution, the new Next Generation Sequencing techniques,and innovative non-invasive neurophysiological methods (Electroencephalogram-Functional magnetic resonance imaging and High Density-Electroencephalogram) could provide a superior identification of the epileptogenic zone and therefore an increased access to epilepsy surgery.
Despite this, patients with cryptogenic epilepsy require more frequently invasive methods of presurgical study and they have more unfavorable results than patients with lesions detectable on magnetic resonance imaging. Within this context, the study is aimed at integrating the neurophysiological, radiological, neuropsychological and genetic aspects of patients with focal cryptogenic epilepsy in order to evaluate their surgical eligibility,sparing invasive methods.
Read the detailed description
The investigators foresee study duration of 36 months and the enrollment of about 20-25 patients, affected by cryptogenic epilepsy with onset during pediatric age (0-18 years), not only to identify the cause of epilepsy and the epileptogenic zone, but also to define in a non-invasive manner, the patient's possible eligibility for surgical therapy.
Innovative neurophysiological methods, such as combined Electroencephalogram-Functional magnetic resonance imaging recording and high resolution electroencephalogram, in addition to 7 Tesla brain magnetic resonance imaging (available through the Imago7 non-profit foundation), neuropsychological studies and genetic tests through Next generation sequencing allow an advanced pre-surgical study free from the risks and discomforts caused by invasive methods. The systematic use of these diagnostic approaches will implement the knowledge and skills of the teams and it will stimulate their use in the clinical daily practise, especially for pediatric patients.
In addition to that, the investigators would like to analyse descriptive indications relating to the diagnostic sensitivity of the combined Electroencephalogram-Functional magnetic resonance imaging recording, High Density-electroencephalogram and 7 Tesla magnetic resonance imaging in the identification of the epileptogenic zone, in patients with cryptogenic focal epilepsy.
- Conditions
- Epilepsies, Partial, Epilepsy Intractable
- Being tested
- Standard of care, Functional magnetic resonance imaging-Electroencephalogram combined analysis, High density- electroencephalogram or 7 Tesla magnetic resonance imaging
- Medical subject headings
- Epilepsies, Partial, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careDiagnostic test
Enrollment of patients afferent to our Center with cryptogenic drug-resistant epilepsy with onset in pediatric age, subject to informed consent;
- acquisition and updating of Electroencephalogram polygraphic data of wakefulness and sleep and neuroradiological data (previous negative brain magnetic resonance imaging);
- execution of a complete neuropsychological assessment for the classification of cognitive aspects and evaluation of executive functions;
- execution of genetic tests through Next generation sequencing epilepsies panel or exome sequencing
Functional magnetic resonance imaging-Electroencephalogram combined analysisDiagnostic test
A functional brain magnetic resonance imaging is executed analysing blood oxygenation level dependent signal.
During the functional recording, a contemporary electroencephalogram is registered in order to analyse the space-time relationship between the epileptic discharges and the bold abnormalities.
High density- electroencephalogram or 7 Tesla magnetic resonance imagingDiagnostic test
In the event that neither the cause nor the epileptogenic area has been identified, we will evaluate the execution of further tests, such as:
- execution of High Density-electroencephalogram recording at "IRCCS Medea di Conegliano" (TV, Italy) (approximately 3 patients / year) for a further electrophysiological definition;
- 7 Tesla brain magnetic resonance imaging performed at "IRCCS Stella Maris in Calambrone" (PI, italy) (approximately 3 patients / year expected), to obtain greater spatial resolution and better neuroradiological definition.
| Study group | Role | What they receive |
|---|---|---|
| IDENTIFICATION OF THE CAUSE OF THE EPILEPSY AND OF THE EPILEPTOGENIC ZONE (sequential approach) | Experimental | Step1: standard of care.
* acquisition and updating of Electroencephalogram polygraphic data of wakefulness and sleep and neuroradiological data
* complete neuropsychological assessment
* genetic tests through Next generation sequencing epilepsies panel, or exome
Step 2: experimental
- combined Electroencephalogram-Functional brain magnetic resonance imaging registration.
Step 3: experimental
In the event that neither the cause nor the epileptogenic area has been identified, we will evaluate the execution of further tests, such as:
* execution of High Density-Electroencephalogram recording at "IRCCS Medea di Conegliano" (TV, Italy) (approximately 3 patients / year) for a further electrophysiological definition;
* 7 Tesla brain magnetic resonance imaging performed at "IRCCS Stella Maris in Calambrone"(PI, Italy) (approximately 3 patients / year expected), to obtain greater spatial resolution and better neuroradiological definition. Receives: Diagnostic Test: Standard of care; Diagnostic Test: Functional magnetic resonance imaging-Electroencephalogram combined analysis; Diagnostic Test: High density- electroencephalogram or 7 Tesla magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the epileptogenic zone.
Identification of the epileptogenic zone. Identification of non-invasive methods (Electroencephalogram-Functional magnetic resonance imaging, High Density-Electroencephalogram and 7 Tesla brain magnetic resonance imaging) in order to provide the necessary and crucial data, allowing the patient access to the epilepsy surgery without recurring to invasive methods. The calculation of the sample size was carried out on the basis of the primary objective of non-invasive identification of the epileptogenic zone. 60 patients will be sufficient to estimate the proportion of subjects treated with an effect size of 0.5, a power of 90% and a first type error of 5%. (60 patients are obtained by including patients from Conegliano).
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Diagnostic sensitivity comparison
Diagnostic sensitivity comparison between combined Electroencephalogram-Functional magnetic resonance imaging and High Density-Electroencephalogram or 7Tesla brain magnetic resonance imaging recording for a patients subgroup.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start15 Jul 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsies, PartialStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefania Zambrano, MD, Principal investigator, Scientific Institute IRCCS Eugenio Medea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05015868
- Sponsor's protocol ID
- 879
- Status last verified
- Apr 2025
- First submitted
- 11 Aug 2021
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Genetics, Non-invasive Neurophysiological Methods, Neuroimaging and Neuropsychology in Identifying the Cause and the Epileptogenic Zone in Focal Cryptogenic Epilepsies
- ClinicalTrials.gov ID
- NCT05015868
- Acronym / sponsor ID
- 879
- Conditions
- Epilepsies, Partial, Epilepsy Intractable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 20 Aug 2021 (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.
Patients with cryptogenic focal epilepsy (unknown cause) represent about the 30% of the entire population of epilepsy patients. Among them, about 30% are drug-resistant. The implementation of of high-field magnetic resonance imaging resolution, the new Next Generation Sequencing techniques,and innovative non-invasive neurophysiological methods (Electroencephalogram-Functional magnetic resonance imaging and High Density-Electroencephalogram) could provide a superior identification of the epileptogenic zone and therefore an increased access to epilepsy surgery.
Despite this, patients with cryptogenic epilepsy require more frequently invasive methods of presurgical study and they have more unfavorable results than patients with lesions detectable on magnetic resonance imaging. Within this context, the study is aimed at integrating the neurophysiological, radiological, neuropsychological and genetic aspects of patients with focal cryptogenic epilepsy in order to evaluate their surgical eligibility,sparing invasive methods.
Detailed description
The investigators foresee study duration of 36 months and the enrollment of about 20-25 patients, affected by cryptogenic epilepsy with onset during pediatric age (0-18 years), not only to identify the cause of epilepsy and the epileptogenic zone, but also to define in a non-invasive manner, the patient's possible eligibility for surgical therapy.
Innovative neurophysiological methods, such as combined Electroencephalogram-Functional magnetic resonance imaging recording and high resolution electroencephalogram, in addition to 7 Tesla brain magnetic resonance imaging (available through the Imago7 non-profit foundation), neuropsychological studies and genetic tests through Next generation sequencing allow an advanced pre-surgical study free from the risks and discomforts caused by invasive methods. The systematic use of these diagnostic approaches will implement the knowledge and skills of the teams and it will stimulate their use in the clinical daily practise, especially for pediatric patients.
In addition to that, the investigators would like to analyse descriptive indications relating to the diagnostic sensitivity of the combined Electroencephalogram-Functional magnetic resonance imaging recording, High Density-electroencephalogram and 7 Tesla magnetic resonance imaging in the identification of the epileptogenic zone, in patients with cryptogenic focal epilepsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IDENTIFICATION OF THE CAUSE OF THE EPILEPSY AND OF THE EPILEPTOGENIC ZONE (sequential approach) | Experimental | Diagnostic Test: Standard of care, Diagnostic Test: Functional magnetic resonance imaging-Electroencephalogram combined analysis, Diagnostic Test: High density- electroencephalogram or 7 Tesla magnetic resonance imagingStep1: standard of care. * acquisition and updating of Electroencephalogram polygraphic data of wakefulness and sleep and neuroradiological data * complete neuropsychological assessment * genetic tests through Next generation sequencing epilepsies panel, or exome Step 2: experimental - combined Electroencephalogram-Functional brain magnetic resonance imaging registration. Step 3: experimental In the event that neither the cause nor the epileptogenic area has been identified, we will evaluate the execution of further tests, such as: * execution of High Density-Electroencephalogram recording at "IRCCS Medea di Conegliano" (TV, Italy) (approximately 3 patients / year) for a further electrophysiological definition; * 7 Tesla brain magnetic resonance imaging performed at "IRCCS Stella Maris in Calambrone"(PI, Italy) (approximately 3 patients / year expected), to obtain greater spatial resolution and better neuroradiological definition. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- focal epilepsy, onset during pediatric age (<18 y)
- drug resistance
- unknown cause
- Brain magnetic resonance imaging negative
Key exclusion criteria (3 listed)
- epilepsy with good therapeutic control
- focal symptomatic epilepsy
- age limits onset (> 18 y)
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 |
|---|---|---|
| Standard of careEnrollment of patients afferent to our Center with cryptogenic drug-resistant epilepsy with onset in pediatric age, subject to informed consent; * acquisition and updating of Electroencephalogram polygraphic data of wakefulness and sleep and neuroradiological data (previous negative brain magnetic resonance imaging); * execution of a complete neuropsychological assessment for the classification of cognitive aspects and evaluation of executive functions; * execution of genetic tests through Next generation sequencing epilepsies panel or exome sequencing | Diagnostic test | IDENTIFICATION OF THE CAUSE OF THE EPILEPSY AND OF THE EPILEPTOGENIC ZONE (sequential approach) |
| Functional magnetic resonance imaging-Electroencephalogram combined analysisA functional brain magnetic resonance imaging is executed analysing blood oxygenation level dependent signal. During the functional recording, a contemporary electroencephalogram is registered in order to analyse the space-time relationship between the epileptic discharges and the bold abnormalities. | Diagnostic test | IDENTIFICATION OF THE CAUSE OF THE EPILEPSY AND OF THE EPILEPTOGENIC ZONE (sequential approach) |
| High density- electroencephalogram or 7 Tesla magnetic resonance imagingIn the event that neither the cause nor the epileptogenic area has been identified, we will evaluate the execution of further tests, such as: * execution of High Density-electroencephalogram recording at "IRCCS Medea di Conegliano" (TV, Italy) (approximately 3 patients / year) for a further electrophysiological definition; * 7 Tesla brain magnetic resonance imaging performed at "IRCCS Stella Maris in Calambrone" (PI, italy) (approximately 3 patients / year expected), to obtain greater spatial resolution and better neuroradiological definition. | Diagnostic test | IDENTIFICATION OF THE CAUSE OF THE EPILEPSY AND OF THE EPILEPTOGENIC ZONE (sequential approach) |
Primary outcome
Identification of the epileptogenic zone.
Time frame: through study completion, an average of 1 year
Identification of the epileptogenic zone. Identification of non-invasive methods (Electroencephalogram-Functional magnetic resonance imaging, High Density-Electroencephalogram and 7 Tesla brain magnetic resonance imaging) in order to provide the necessary and crucial data, allowing the patient access to the epilepsy surgery without recurring to invasive methods. The calculation of the sample size was carried out on the basis of the primary objective of non-invasive identification of the epileptogenic zone. 60 patients will be sufficient to estimate the proportion of subjects treated with an effect size of 0.5, a power of 90% and a first type error of 5%. (60 patients are obtained by including patients from Conegliano).
1 secondary outcome
Diagnostic sensitivity comparison
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
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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. This study is not recruiting at the moment.
Stefania Zambrano, MD principal investigator
Scientific Institute IRCCS Eugenio Medea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional magnetic resonance imaging-Electroencephalogram combined analysis and High density- electroencephalogram or 7 Tesla magnetic resonance imaging in people with Epilepsies, Partial and Epilepsy Intractable, 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 1 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of the epileptogenic zone. (time frame: through study completion, an average of 1 year). 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 1 May 2025.