RecruitingNAINTERVENTIONAL

Contribution of Fast-ripples to the Improvement of the Neurosurgical Management of Drug-refractory Epilepsy

This research is for people in France with epilepsy that hasn't improved with medication. It's investigating if a new way of recording brain activity, using special tiny electrodes alongside standard ones, can help surgeons better pinpoint where seizures start. Currently, doctors use standard recordings to plan surgery. This study will see if adding information from these new 'hybrid' electrodes, which can pick up very fast electrical signals called 'fast ripples', leads to more successful surgery. Researchers will compare two groups: one where doctors get this extra 'fast ripple' information, and another where they only get standard information. The main goal is to see if using the new method helps more people become seizure-free one year after surgery.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Toulouse

Enrolment target

440

Start

19 Jan 2024

Estimated completion

01 Apr 2030

Epilepsy

What is this study about?

This study is for adults in France who have epilepsy that hasn't been controlled by medicines. It focuses on a type of brain surgery that can help some people become seizure-free. Before this surgery, doctors need to find the exact part of the brain causing the seizures. This is usually done by placing small wires, called electrodes, inside the brain to record its electrical activity. This procedure is called Stereo-ElectroEncephaloGraphy, or SEEG.

Researchers want to see if a newer method can improve how doctors find where seizures start. This new method uses special 'hybrid' electrodes, which are tiny and can pick up very fast electrical signals called 'fast ripples'. These fast ripples might give more clues about the seizure's origin. The study will compare two groups of patients. One group will have the standard brain recordings, and doctors will also get information from these new hybrid electrodes, hopefully leading to a more precise surgical plan. The other group will only have the standard recordings, just like current practice.

The main aim is to find out if using this extra 'fast ripple' information helps more people to be free from their disabling seizures one year after surgery. By comparing the two groups, the researchers hope to understand if this new technique can lead to better outcomes for people living with epilepsy.

Key takeaways

This study explores a new way to find seizure sources in drug-resistant epilepsy.
It compares standard brain recordings with a newer method using special 'hybrid' electrodes.
The goal is to see if the new method leads to better surgical outcomes (fewer seizures).
Participation involves undergoing the SEEG procedure, with some differences for the two groups.
The study is for adults in France with epilepsy not controlled by medication.

Who may be eligible?

To be considered for this study, you must be an adult between 18 and 65 years old and living in France, covered by the French healthcare system. You should have focal epilepsy, meaning your seizures start in a specific part of your brain, and your epilepsy hasn't responded well to medication (it's called 'drug-resistant'). Your medical team would have already decided that the SEEG procedure is a good option for you.

There are certain reasons why you wouldn't be able to join. These include if you are under legal protection that restricts your ability to make decisions, or if you are in prison. Also, if you have a heart pacemaker or defibrillator, or if you're already taking part in another study, you wouldn't be eligible. Lastly, if your doctors are planning a specific heat treatment (thermocoagulation) on one of the areas where the special hybrid electrodes might be placed, you also couldn't 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 between 18 and 65 years old?
Do you live in France and are you covered by the French healthcare system?
Has your medical team recommended SEEG for your epilepsy?
Has your epilepsy not been controlled by medications?
Do you not have a heart pacemaker/defibrillator or are you not involved in another study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be undergoing the SEEG procedure as planned for your epilepsy treatment. For about half of the participants, some of your usual electrodes (between 4 and 6) will be replaced with these new 'hybrid' electrodes during the procedure. For these special electrodes, your brain activity will be recorded for one hour while you are resting, on two different days during your first week with the SEEG. If possible, there will also be recordings during one night's sleep. Experts will then look at these recordings to find the 'fast ripples'. This information, along with your other medical details, will then be discussed by your medical team to help plan your surgery. The other half of the participants will have standard electrodes only, and no extra 'fast ripple' recordings will be taken or used for their surgical planning. All decisions about your surgery will be made within 4 to 6 months after your SEEG.

Potential risks and benefits

Taking part in this study could potentially lead to a better understanding of your epilepsy, which might help your doctors plan more effective surgery to reduce or stop your seizures. However, as with any medical procedure, there are potential risks, primarily those associated with the SEEG itself, and the insertion of the electrodes. While the hybrid electrodes are designed to be safe, their use is part of this research. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (11)

CHU Amiens Picardie
Verified postcode
Amiens, France· Recruiting
University hospital of Bordeaux
Verified postcode
Bordeaux, France· Recruiting
University hospital of Grenoble Alpes
Verified postcode
La Tronche, France· Recruiting
APHP Hôpital Bicêtre
Verified postcode
Le Kremlin-Bicêtre, France· Recruiting
CHU de Lille
Verified postcode
Lille, France· Recruiting
Hospices Civils de Lyon
Verified postcode
Lyon, France· Recruiting
CHRU de Nancy
Verified postcode
Nancy, France· Recruiting
Fondation Adolphe de Rothschild
Verified postcode
Paris, France· Not yet recruiting
CHU de Rennes
Verified postcode
Rennes, France· Recruiting
Hôpitaux universitaires de Strasbourg
Verified postcode
Strasbourg, France· Recruiting
University Hospital of Toulouse
Verified postcode
Toulouse, France· Recruiting

Common questions

What is 'drug-refractory epilepsy'?

It means your epilepsy hasn't improved or stopped, even after trying several different epilepsy medications.

What is SEEG?

SEEG stands for Stereo-ElectroEncephaloGraphy. It's a procedure where small wires are placed in your brain to record electrical activity and help doctors find where seizures start.

What are 'fast ripples'?

Fast ripples are very rapid electrical signals in the brain that researchers believe could help pinpoint the exact area causing seizures more accurately.

Will I know if I'm in the 'hybrid electrode' group?

Yes, if you participate in the study, you will be informed which group you are in.

What happens if I decide not to join the study?

Your medical care will not be affected. You will still receive the standard care and procedures recommended by your medical team.

How to find out more

Luc VALTON, MD

valton.l@chu-toulouse.fr 0561775608 Official trial record

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