Finding signs that predict who responds to thermocoagulation in drug-resistant focal epilepsy
Studies brain scans, recordings and blood tests in people with drug-resistant focal epilepsy.
Key facts
- Who runs it
- Assistance Publique Hopitaux De Marseille
- Where
- Marseille, FranceSee the site
- Trial code
- Registry title
- Biomarkers of Response to SEEG Thermocoagulation
- Status
- Recruiting
- People taking part
- 45 people, planned
- Started
- 19 Jun 2026
- Expected to end
- 30 Jun 2029
- Type of study
- Interventional
- Treatments tested
- Quality of life questionnaires (QOLIE, EFIQUACEE for children), psychiatric questionnaires (NDDIE, GAD-7, PCL-5) at Visit 1 (V1), V5, V6 and V7
- Resting state SEEG recording 30min before and 30 min after RFTC
- Blood sample at Visit 1 (V1), V2, V4 and V5
- SEEG electrodes tissue-traces sample at V3 (during SEEG electrodes ablation)
- Multiparametric 3T MRI with gadolinium at V1, V4 and V5
- Multiparametric 7T MRI at V1 and V5
- Record updated
- 26 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 12 or older with drug-resistant focal epilepsy who are going to have a SEEG exploration (electrodes placed in the brain) before possible surgery.
- Age
- 12 years or older
- Sex
- All sexes can join.
- Disease stage
- Drug-resistant focal epilepsy, with a standard pre-surgical work-up (medical history, scalp video-EEG and 3T MRI) done.
- Earlier treatment
- A SEEG exploration for pre-surgical evaluation must have been indicated.
Main reasons for not taking part
- Epilepsy surgery done without the need for SEEG
- Cannot have a 3T or 7T brain MRI (for example a pacemaker or metal in the body)
- Cannot have gadolinium contrast (allergy, severe kidney failure, dialysis, kidney disease)
- Pregnant or breastfeeding women, or people in other protected situations
- Currently in the exclusion period of another study
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 L1121-8 of the Public Health Code (pregnant or breastfeeding woman, deprived of liberty by judicial decision, situations of social fragility, adults unable or unable to express their consent),
- Patient in exclusion period of another study
Where in France
- Assistance Publique - Hôpitaux MarseilleMarseille, FranceContact: Julia MAKHALOVATaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- SEEG patientsTreatment being tested
Treatment: Quality of life questionnaires (QOLIE, EFIQUACEE for children), psychiatric questionnaires (NDDIE, GAD-7, PCL-5) at Visit 1 (V1), V5, V6 and V7, Resting state SEEG recording 30min before and 30 min after RFTC, Blood sample at Visit 1 (V1), V2, V4 and V5, SEEG electrodes tissue-traces sample at V3 (during SEEG electrodes ablation), Multiparametric 3T MRI with gadolinium at V1, V4 and V5, and Multiparametric 7T MRI at V1 and V5
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Biomarkers of Response to SEEG Thermocoagulation in Patients With Refractory Focal Epilepsy
- Plain-language title
- Finding signs that predict who responds to thermocoagulation in drug-resistant focal epilepsyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 26 June 2026