RecruitingNot Applicable

Biomarkers of Response to SEEG Thermocoagulation

France45 participantsStarted 2026-06-19

Plain-language summary

Drug-resistant focal epilepsy is a severe neurological disease that affects one-third of patients with epilepsy. Surgery is the only potentially curative treatment. Intracerebral exploration by stereo electroencephalography (SEEG) is an important step in the surgical pathway. It aims to establish the precise mapping of the epileptogenic network (EZN), including all the brain regions that generate seizures. At the end of SEEG, SEEG-guided radiofrequency thermocoagulation (SEEG RFTC) represents a therapeutic option that may be efficient as a palliative treatment in patients ineligible for resective surgery, or may lead, in some cases, to a definitive effect, avoiding open surgery. The safety and effectiveness of this approach have been established. However, the odds of remaining seizure-free after one year vary greatly between studies, ranging from 4% to 71%. This disparity in therapeutic responses could be linked to the absence of objective criteria for the selection of targets, but also to the existence of mechanisms of action outside of the direct lesional effect. A decrease in SEEG markers of epileptogenicity may predict thermocoagulation efficiency. However, no data are available regarding changes in alteration of the blood-brain barrier (BBB) connectivity, inflammation, or associated molecular changes and their relationship to prognosis. This study aims to elucidate the mechanisms underlying the clinical effect of SEEG RFTC by studying the changes in electrophysiological (SEEG), structural (ultra-high field MRI), and biological (blood biomarkers of neuro-glio-vascular damage and inflammation, molecular adaptations) markers. They will be correlated with clinical outcome in a prospective cohort of patients with drug-resistant focal epilepsy. As advantages for clinical care, this study will allow selection of RFTC targets based on scientifically validated criteria, and elaboration of predictive scores for therapeutic response in each patient. The primary objective is to study the predictive factors of response to SEEG RFTC, by correlating changes in BBB permeability with clinical response 3 months after RFTC, in a prospective cohort of patients with drug-resistant focal epilepsy.

Who can participate

Age range

12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient, parents or legal representative who have given their written informed consent, * Adult or pediatric patient ≥ 12 years old suffering from drug-resistant focal epilepsy, * Standardized pre-surgical assessment including medical history, scalp video-EEG and 3T MRI, * Patients in whom a SEEG exploration for pre-surgical evaluation has been indicated, * Patient able to understand, speak and write in French, * Patient able to follow study's procedure, * Patient beneficiary or affiliated to a health insurance plan. Exclusion Criteria: * Epilepsy surgery performed without the requirement of SEEG, * Contraindication to 3T or 7T brain MRI (patient with a cardiac pacemaker, metallic foreign bodies, non-removable implanted electronic medical devices, claustrophobia, inability to remain in supine position, patient havingwith Vagus Nerve Stimulation (VNS) or Deep Brain Sstimulation (DBS), intrauterine devices or tattoos in the imaging area less than 6 weeks old at the time of the 3T/7T brain MRI), * Contraindication to gadolinium-based MRI contrast agent (history of allergic or anaphylactic reaction to gadolinium, hypersensitivity to gadoteric acid, meglumine, or any drug containing gadolinium, severe renal failure (glomerular filtration rate, GFR, below 30 ml/min/1.73 m2), patients on dialysis or with a history of kidney disease, such as renal transplantation, a single kidney, or renal malignancy), * Person protected by articles L1121-5, L1121-6 and L1121…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Relationship between changes in the MRI biomarker of BBB permeability (the transfer coefficient, Ki) and clinical response (responder vs non responder) at 3 months after RFTC

Timeframe: From baseline before SEEG to 3 months after RFTC

Trial details

NCT IDNCT07399327

SponsorAssistance Publique Hopitaux De Marseille

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-01-31

Contact for this trial

Julia MAKHALOVA-SCHOLLY

0491384990 Julia.SCHOLLY@ap-hm.fr

View on ClinicalTrials.gov More Drug Resistant Epilepsy trials