RecruitingNAINTERVENTIONAL

Cartography of Social Cognition Network and Their Alterations in Patients With Epilepsy

This study aims to understand how epilepsy affects social awareness and interaction. We all use 'social cognition' to understand others and behave appropriately. However, many people with epilepsy, especially a type called temporal lobe epilepsy, find this difficult, which can impact their daily lives. We are using two types of advanced MRI scans (3T and 7T MRI) to create detailed maps of the brain's social networks. We will compare these maps in 20 healthy volunteers and 20 people with drug-resistant temporal lobe epilepsy, both before and one year after their epilepsy surgery. Our goal is to uncover the brain changes that cause these difficulties and see how they might change after surgery.

At a glance

Status

Recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

Start

19 Mar 2025

Estimated completion

19 Jan 2029

Epilepsy Drug Resistant Epilepsy

What is this study about?

Imagine being able to easily understand what someone else is thinking or feeling, or knowing how to act appropriately in different social situations. This ability is called 'social cognition,' and it's something most of us do without a second thought. However, for many people living with epilepsy, especially a type called temporal lobe epilepsy, these skills can be difficult. This can make everyday life challenging and affect their overall well-being, but we don't fully understand why this happens.

This research project aims to shed light on these unanswered questions. We want to create very detailed 'maps' of the brain networks involved in social cognition. We'll be comparing these maps between healthy individuals and those with drug-resistant temporal lobe epilepsy. By doing this, we hope to identify specific differences in brain structure and function that contribute to social cognition difficulties in epilepsy. We're particularly interested in seeing how these brain networks might change after epilepsy surgery.

To create these detailed brain maps, we will be using two advanced types of MRI scanners (3-Tesla MRI and 7-Tesla MRI). These aren't like regular MRI scans; they allow us to see much more detail about the connections and activity within the brain. By combining all this information, our goal is to gain a clearer picture of how social cognition is affected by epilepsy and how brain surgery might help improve these vital social abilities.

Key takeaways

This study explores how epilepsy affects social understanding.
It uses advanced MRI to map brain networks in people with and without epilepsy.
Patients with drug-resistant temporal lobe epilepsy are studied before and after surgery.
The goal is to understand brain changes and how surgery might help.
It aims to improve future understanding and treatment for epilepsy patients.

Who may be eligible?

To join this study, you need to be an adult over 18 years old and able to understand and speak French well. You’ll also need to be signed up with a social security system.

If you have had epilepsy for at least a year, specifically a type of focal temporal lobe epilepsy that hasn't responded well to medication (drug-resistant), and it's due to something called hippocampal sclerosis, you might be suitable. You also need to be preparing for epilepsy surgery.

There are some reasons why you couldn't take part. This includes being pregnant or breastfeeding, having claustrophobia, or any other reason why you can't have an MRI scan. Also, if you’re already in another study with a waiting period, or if you refuse to be told of any unexpected findings from your MRI, you unfortunately wouldn't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Can you understand and speak French well?
Do you have focal temporal lobe epilepsy that hasn't responded to medication (drug-resistant) and are you planning surgery?
Are you not pregnant or breastfeeding?
Do you feel comfortable having an MRI scan (no claustrophobia or other reasons you can't have one)?
Are you not currently part of another clinical study with an overlapping exclusion period?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have several appointments. You will have special tests to check your social skills, which involve answering questions and doing tasks. You'll also have advanced MRI scans, including 3-Tesla and 7-Tesla MRI, which are like very detailed brain pictures. These scans will look at different parts of your brain and how they connect both when your brain is resting and when you're doing certain social tasks.

If you are part of the group with epilepsy, some of these assessments and scans will happen before your planned epilepsy surgery. Then, about one year after your surgery, you will have the same assessments and scans again to see if there have been any changes. The total time you'd be involved in the study would be about one year.

Potential risks and benefits

Taking part in this study won't directly improve your health, as it's a research project to understand more about epilepsy and the brain. However, the information we learn could help other people with epilepsy in the future. The main risks involve the MRI scans; these are generally safe, but some people might feel claustrophobic or uncomfortable lying still in the scanner. The researchers will explain all potential risks and discomforts to you in detail. Remember, joining this study is completely voluntary, and you have the right to change your mind and withdraw at any time, without it affecting your medical care.

Locations (2)

NeuroSpin - CEA
Verified postcode
Gif-sur-Yvette, France· Active not recruiting
Unité d'épilepsie - GHU Pitié Salpêtrière
Verified postcode
Paris, France· Recruiting

Common questions

What is 'social cognition'?

It's your ability to understand social situations, including what others might be feeling or thinking, and how to act appropriately.

What's the difference between 3T and 7T MRI?

Both are advanced MRI scans, but a 7T MRI is even more powerful and can show incredibly fine details and connections in the brain that a 3T MRI might not.

Will I get results from my scans?

The study aims to understand groups of people, not individual diagnoses. However, if an unexpected, medically important finding is seen on your scan, you would be informed.

Do I have to stop my epilepsy medication for this study?

No, your epilepsy medication will not be changed for the purpose of this study. You will continue with your usual treatment.

Will I have to travel for the appointments?

The study will involve visits to the research centre where the MRI scanners are located. The research team will provide more details about travel and locations.

How to find out more

Bastien HERLIN, MD, PH

bastien.herlin@php.fr 1 42 16 03 01 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.