Biomarkers of Response to SEEG Thermocoagulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study examines biomarker signals associated with response to SEEG-guided radiofrequency thermocoagulation in patients with drug-resistant focal epilepsy. Participants undergo SEEG with tissue sampling, qol and psychiatric questionnaires, and multiparametric MRI to explore predictors of seizure outcomes. Resting-state SEEG is recorded before and after the procedure, alongside blood tests and pediatric/adult quality of life assessments. The Trial uses an observational/interventional design to correlate biomarkers with seizure outcomes and quality-of-life changes over the follow-up period. Safety and feasibility of the approach are evaluated within the surgical and imaging workflow.

Why it matters

Who can join: the full rules

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 L1121-8 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 it's running

• Assistance Publique - Hôpitaux Marseille
  Marseille, France Recruiting

Study contacts

• Study coordinator: Julia MAKHALOVA-SCHOLLY
• Email: Julia.SCHOLLY@ap-hm.fr
• Phone: 0491384990

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.