EpilepsiesRMNEPI22NCT07881185
Artificial Intelligence for Brain MRI Analysis in Epilepsy
An observational study of Epilepsies, run by Istituto Giannina Gaslini at 23 sites in 13 countries.
Trial summary
This study will test computer programs that help doctors read brain MRI scans. The programs use artificial intelligence (AI). The study includes people with epilepsy, a condition that causes repeated seizures. Brain changes linked to epilepsy can be hard to see on an MRI (magnetic resonance imaging) scan. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsies
- How many people
- 2,000 participants
- Where
- 23 sitesin 13 countries
- Study dates
- 30 May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with epilepsy of any cause who are treated at participating centers worldwide. They have a brain MRI scan as part of routine clinical care. About 2,000 people will be enrolled consecutively. Some of them may later have epilepsy surgery.
Who may be able to join
- Informed consent signed
Who cannot join
- Informed consent not signed
Trial locations and contacts
23 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
23 sites in 13 countries
United States6 sites, 6 recruiting
- Recruiting
National Institute of Health (NINDS-Intramural)
Bethesda, Maryland, 20892
NA NA
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
NA NA
- Recruiting
Rush Hospital
Chicago, Illinois, 60612
NA NA
- Recruiting
University of California
Oakland, California, 94607
NA NA
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
NA NA
- Recruiting
George Washington University
Washington D.C., District of Columbia, 20052
NA NA
Italy6 sites, 6 recruiting
- Recruiting
University of Cagliari
Cagliari, 09124
NA NA
- Recruiting
University of Catanzaro
Catanzaro, 88100
NA NA
- Recruiting
Istituto di Tecnologie Avanzate Biomediche, University D'Annunzio
Chieti, 66100
NA NA
- Recruiting
IRCCS Istituto Giannina Gaslini
Genova, 16147
Pasquale Striano, MD, +39 010 5636 2912, pasqualestriano@gaslini.org
Pasquale Striano, MD
- Recruiting
University of Messina
Messina, 98122
NA NA
- Recruiting
University of Modena and Reggio Emilia
Modena, 41121
NA NA
Australia1 site, 1 recruiting
- Recruiting
The Florey Institute of Neuroscience and Mental Health
Melbourne, 3052
NA NA
Belgium1 site, 1 recruiting
- Recruiting
Université Libre de Bruxelles
Brussels, 1050
NA NA
Brazil1 site, 1 recruiting
- Recruiting
University of Campinas
Campinas, 13083-872
NA NA
Canada1 site, 1 recruiting
- Recruiting
Multimodal Imaging and Connectome Analysis Laboratory (Montreal Neurological Institute and Hospital, McGill University)
Montreal, H3A2B4
NA NA
Germany1 site, 1 recruiting
- Recruiting
University Hospital Bonn
Bonn, 53127
NA NA
Mexico1 site, 1 recruiting
- Recruiting
Autonomous University of Mexico
Mexico City, 04510
NA NA
South Africa1 site, 1 recruiting
- Recruiting
University of Cape Town
Cape Town, 7700
NA NA
Spain1 site, 1 recruiting
- Recruiting
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Barcelona, 08036
NA NA
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
NA NA
United Kingdom1 site, 1 recruiting
- Recruiting
University College of London
London, WC1E 6BT
NA NA
About this study
Official title: Implementazione di Algoritmi di Intelligenza Artificiale Nello Studio Delle RMN Cerebrali di Pazienti Con Epilessia / Implementation of Artificial Intelligence Algorithms for the Analysis of Brain MRI Scans in Patients With Epilepsy
This study will test computer programs that help doctors read brain MRI scans. The programs use artificial intelligence (AI). The study includes people with epilepsy, a condition that causes repeated seizures.
Brain changes linked to epilepsy can be hard to see on an MRI (magnetic resonance imaging) scan. Different doctors may read the same scan in different ways. The researchers want to build AI tools that help doctors find these changes earlier. Earlier findings could lead to a faster diagnosis. They could also help doctors decide if a genetic test or a brain surgery evaluation is right for a patient.
Read more
The researchers also want to learn if AI can predict how well epilepsy surgery will work. If it can, surgeons could use the tool to plan an operation. The goal is to stop seizures while protecting parts of the brain that control speech and sight.
Who can take part? People with epilepsy who are treated at the Gaslini Institute or another study center Adults who give their own written consent Children whose parent or caregiver gives written consent People who do not agree to take part cannot be included.
What will happen? The researchers will collect brain MRI scans from about 2,000 people. The scans come from regular clinical care.
The researchers will replace each person's name on the scan with a code number. The coded scans go to a secure online portal. Study centers around the world share this portal.
One trained researcher will run the AI programs on the scans. The researchers will keep the scans for 2 years to build an image library. The researchers will compare the scans with health information. They want to find signs in the scans that show how epilepsy may change over time.
This study does not test a new medicine or treatment. It will last about 2 years.
- Conditions
- Epilepsies
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with epilepsy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Create a large database of brain MRI scans from patients with epilepsy of various etiologies, referred to multiple highly specialized centers worldwide
Create a large database of brain MRI scans from patients with epilepsy of various etiologies, referred to multiple highly specialized centers worldwide
Measured: Up to 24 months
Develop artificial intelligence (AI) algorithms that facilitate the detection of lesions on neuroimaging acquired during routine clinical practice
Develop artificial intelligence (AI) algorithms that facilitate the detection of lesions on neuroimaging acquired during routine clinical practice
Measured: Up to 24 months
Secondary outcomes (1)
Implement the algorithms to predict outcomes in the subpopulation of patients who are eligible for, and undergo, epilepsy surgery.
Implement the algorithms to predict outcomes in the subpopulation of patients who are eligible for, and undergo, epilepsy surgery. Neurosurgeons will be able to use this computational tool to simulate and plan the surgical procedure with the best chance of curing the patient while preserving eloquent brain areas (e.g., language and visual areas).
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start30 May 2023
- Primary completion31 Dec 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 EpilepsiesStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881185
- Sponsor's protocol ID
- RMNEPI22 (12869)
- Acronym
- RMNEPI22
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementazione di Algoritmi di Intelligenza Artificiale Nello Studio Delle RMN Cerebrali di Pazienti Con Epilessia / Implementation of Artificial Intelligence Algorithms for the Analysis of Brain MRI Scans in Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT07881185
- Acronym / sponsor ID
- RMNEPI22 / RMNEPI22 (12869)
- Conditions
- Epilepsies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Oct 2026 (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.
This study will test computer programs that help doctors read brain MRI scans. The programs use artificial intelligence (AI). The study includes people with epilepsy, a condition that causes repeated seizures.
Brain changes linked to epilepsy can be hard to see on an MRI (magnetic resonance imaging) scan. Different doctors may read the same scan in different ways. The researchers want to build AI tools that help doctors find these changes earlier. Earlier findings could lead to a faster diagnosis. They could also help doctors decide if a genetic test or a brain surgery evaluation is right for a patient.
The researchers also want to learn if AI can predict how well epilepsy surgery will work. If it can, surgeons could use the tool to plan an operation. The goal is to stop seizures while protecting parts of the brain that control speech and sight.
Who can take part? People with epilepsy who are treated at the Gaslini Institute or another study center Adults who give their own written consent Children whose parent or caregiver gives written consent People who do not agree to take part cannot be included.
What will happen? The researchers will collect brain MRI scans from about 2,000 people. The scans come from regular clinical care.
The researchers will replace each person's name on the scan with a code number. The coded scans go to a secure online portal. Study centers around the world share this portal.
One trained researcher will run the AI programs on the scans. The researchers will keep the scans for 2 years to build an image library. The researchers will compare the scans with health information. They want to find signs in the scans that show how epilepsy may change over time.
This study does not test a new medicine or treatment. It will last about 2 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People with epilepsy | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with epilepsy of any cause who are treated at participating centers worldwide. They have a brain MRI scan as part of routine clinical care. About 2,000 people will be enrolled consecutively. Some of them may later have epilepsy surgery.
Key inclusion criteria (1 listed)
- Informed consent signed
Key exclusion criteria (1 listed)
- Informed consent not signed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Create a large database of brain MRI scans from patients with epilepsy of various etiologies, referred to multiple highly specialized centers worldwide
Time frame: Up to 24 months
Create a large database of brain MRI scans from patients with epilepsy of various etiologies, referred to multiple highly specialized centers worldwide
Develop artificial intelligence (AI) algorithms that facilitate the detection of lesions on neuroimaging acquired during routine clinical practice
Time frame: Up to 24 months
Develop artificial intelligence (AI) algorithms that facilitate the detection of lesions on neuroimaging acquired during routine clinical practice
1 secondary outcome
Implement the algorithms to predict outcomes in the subpopulation of patients who are eligible for, and undergo, epilepsy surgery.
Time frame: Up to 24 months
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 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
23 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsies, run by Istituto Giannina Gaslini at 23 sites in 13 countries.
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 1 inclusion and 1 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Italy, Australia, Belgium, Brazil and 8 more countries. 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 Pasquale Striano, MD (+39 010 5636 2912, pasqualestriano@gaslini.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Create a large database of brain MRI scans from patients with epilepsy of various etiologies, referred to multiple highly specialized centers worldwide (time frame: Up to 24 months). The study lists 2 primary outcomes in all. 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 19 Oct 2026.