NCT07881185 · Istituto Giannina Gaslini
Artificial Intelligence for Brain MRI Analysis in Epilepsy
(RMNEPI22)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \- Informed consent signed
Exclusion criteria
- \- Informed consent not signed
Where
- Oakland, California
- Washington D.C., District of Columbia
- Chicago, Illinois
- Bethesda, Maryland
- Philadelphia, Pennsylvania
- Charleston, South Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 19, 2026 · Source of record for eligibility and locations