ClinicalTrials.gg
RecruitingNCT07881185RMNEPI22Updated Oct 19, 2026

Artificial Intelligence for Brain MRI Analysis in Epilepsy

An observational study in Epilepsies, sponsored by Istituto Giannina Gaslini. Recruiting at 23 sites in 13 countries. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Istituto Giannina Gaslini · Observational

From the registry’s dates

  • Started May 2023; still recruiting 3 years 4 months later.
Updated Oct 19, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Epilepsies

Browse trials for

03

In context

Epilepsy

1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 101 across 536 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Istituto Giannina Gaslini is the lead sponsor of 50 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- Informed consent signed

Exclusion criteria

Exclusion Criteria:

- Informed consent not signed

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • People with epilepsy
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 24 months

  2. 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

    Time frame: 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).

    Time frame: Up to 24 months

07

Study locations

23 of 23 sites recruiting
  • University of California
    Oakland, California 94607, United States
    • NA NA · Contact
    Recruiting
  • George Washington University
    Washington D.C., District of Columbia 20052, United States
    • NA NA · Contact
    Recruiting
  • Rush Hospital
    Chicago, Illinois 60612, United States
    • NA NA · Contact
    Recruiting
  • National Institute of Health (NINDS-Intramural)
    Bethesda, Maryland 20892, United States
    • NA NA · Contact
    Recruiting
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
    • NA NA · Contact
    Recruiting
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
    • NA NA · Contact
    Recruiting
  • The Florey Institute of Neuroscience and Mental Health
    Melbourne, 3052, Australia
    • NA NA · Contact
    Recruiting
  • Université Libre de Bruxelles
    Brussels, 1050, Belgium
    • NA NA · Contact
    Recruiting
  • University of Campinas
    Campinas, 13083-872, Brazil
    • NA NA · Contact
    Recruiting
  • Multimodal Imaging and Connectome Analysis Laboratory (Montreal Neurological Institute and Hospital, McGill University)
    Montreal, H3A2B4, Canada
    • NA NA · Contact
    Recruiting
  • Nanjing University
    Nanjing, 210023, China
    • NA NA · Contact
    Recruiting
  • University Hospital Bonn
    Bonn, 53127, Germany
    • NA NA · Contact
    Recruiting
  • University of Cagliari
    Cagliari, 09124, Italy
    • NA NA · Contact
    Recruiting
  • University of Catanzaro
    Catanzaro, 88100, Italy
    • NA NA · Contact
    Recruiting
  • Istituto di Tecnologie Avanzate Biomediche, University D'Annunzio
    Chieti, 66100, Italy
    • NA NA · Contact
    Recruiting
  • IRCCS Istituto Giannina Gaslini
    Genova, 16147, Italy
    Recruiting
  • University of Messina
    Messina, 98122, Italy
    • NA NA · Contact
    Recruiting
  • University of Modena and Reggio Emilia
    Modena, 41121, Italy
    • NA NA · Contact
    Recruiting
  • Autonomous University of Mexico
    Mexico City, 04510, Mexico
    • NA NA · Contact
    Recruiting
  • University of Cape Town
    Cape Town, 7700, South Africa
    • NA NA · Contact
    Recruiting
  • Institut d'Investigacions Biomèdiques August Pi i Sunyer
    Barcelona, 08036, Spain
    • NA NA · Contact
    Recruiting
  • University Hospital Zurich
    Zurich, 8091, Switzerland
    • NA NA · Contact
    Recruiting
  • University College of London
    London, WC1E 6BT, United Kingdom
    • NA NA · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2023 (actual). Primary completion is estimated for Dec 2026, 43 months after the start.

Of 190 non-industry observational studies under Epilepsy, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 179. This study's planned 43 months is below that.

Counting every sponsor, half of 228 studies reached it within 59 months; a quarter within 29 and three quarters within 119.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 12, 2026
First posted
Oct 19, 2026
StartActual
May 30, 2023
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07881185
Lead sponsor
Istituto Giannina Gaslini
Responsible party
Sponsor
First posted
Oct 19, 2026
Start date
May 30, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 19, 2026

Study contacts

Pasquale Striano, MD
Contact
pasqualestriano@gaslini.org
+39 010 5636 2912

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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