Drug Resistant EpilepsyTHALPONCT07399327
Biomarkers of Response to SEEG Thermocoagulation
A study testing 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 and Blood sample at Visit 1 (V1), V2, V4 and V5 in people with Drug Resistant Epilepsy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Drug Resistant Epilepsy
- What is being 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 and Blood sample at Visit 1 (V1), V2, V4 and V5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jun 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hôpitaux Marseille
Marseille
Julia MAKHALOVA
About this study
Official title: Biomarkers of Response to SEEG Thermocoagulation in Patients With Refractory Focal Epilepsy
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.
- Conditions
- Drug Resistant Epilepsy
- Being 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
- Keywords
- RFTC, Drug resistant epilepsy, SEEG
- Medical subject headings
- Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life questionnaires (QOLIE, EFIQUACEE for children), psychiatric questionnaires (NDDIE, GAD-7, PCL-5) at Visit 1 (V1), V5, V6 and V7Other
This intervention consists in the completion of diverse questionnaires assessing the quality of life of the subject. These questionnaires include:
- quality of life questionnaires: QOLIE or EFICACEE for children
- psychiatric questionnaires NDDIE, GAD-7, PCL-5 These questionnaires will be performed during V1, V5, V6 and V7
Resting state SEEG recording 30min before and 30 min after RFTCOther
During this intervention a resting state SEEG recording will be performed before and after RFTC. These recordings will last for 30 minutes each.
Blood sample at Visit 1 (V1), V2, V4 and V5Other
Blood samples will be collected at Visit 1 (V1), V2, V4 and V5. 2 tubes of 2 ml EDTA will be collected during these visits
SEEG electrodes tissue-traces sample at V3 (during SEEG electrodes ablation)Other
During this intervention, investigators will collect brain tissue samples on SEEG electrodes during their extraction.
Multiparametric 3T MRI with gadolinium at V1, V4 and V5Other
3T MRI with gadolinium injections will be performed at V1, V4 and V5.
Multiparametric 7T MRI at V1 and V5Other
Patients will undergo 7T MRI at V1 and V5
| Study group | Role | What they receive |
|---|---|---|
| SEEG patients | Experimental | Not described Receives: Other: Quality of life questionnaires (QOLIE, EFIQUACEE for children), psychiatric questionnaires (NDDIE, GAD-7, PCL-5) at Visit 1 (V1), V5, V6 and V7; Other: Resting state SEEG recording 30min before and 30 min after RFTC; Other: Blood sample at Visit 1 (V1), V2, V4 and V5; Other: SEEG electrodes tissue-traces sample at V3 (during SEEG electrodes ablation); Other: Multiparametric 3T MRI with gadolinium at V1, V4 and V5; Other: Multiparametric 7T MRI at V1 and V5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Correlation between changes in the MRI biomarker of BBB permeability (the transfer coefficient, Ki), assessed using 3T MRI before SEEG and 3 months after RFTC and clinical response (responder, non-responder) at 3 months after RFTC.
Measured: From baseline before SEEG to 3 months after RFTC
Secondary outcomes (7)
Relationship between changes in MRI biomarkers of microstructural damage, large-scale 7T structural connectivity and functional connectivity response at 3 months after RFTC.
Correlation between changes in MRI biomarkers of microstructural damage (7T T1 longitudinal relaxation time, T2* effective transversal relaxation time, and tissue susceptibility), large-scale 7T structural connectivity (connectivity strengths assessed using DWI MRI) and functional connectivity (Pearson's correlation coefficient using BOLD resting state fMRI) assessed using 7T MRI before SEEG and 3 months after RFTC, and the clinical response (responder, non responder) at 3 months after RFTC.
Measured: From baseline before SEEG to 3 months after RFTC.
Relationship between changes in MRI biomarkers of BBB permeability, microstructural damage, large-scale 7T structural connectivity and functional connectivity and clinical response at 6-12 months after RFTC.
Correlation between changes in MRI biomarkers of BBB permeability (transfer coefficient, Ki), microstructural damage (7T T1 longitudinal relaxation time, T2* effective transversal relaxation time, and tissue susceptibility), structural connectivity (connectivity strengths assessed using DWI MRI), functional connectivity (Pearson's correlation coefficient using BOLD resting state fMRI), assessed using 3T/7T MRI before SEEG and 3 months after RFTC, and the clinical response (responder vs. non responder; percentage change in seizure frequency) at 6 months and 12 months after RFTC
Measured: From baseline before SEEG to 6 months and 12 months after RFTC
Relationship between changes in interictal SEEG-biomarkers (spikes- and HFO rates, power spectrum density (PSD), functional connectivity and clinical response at 3, 6 and 12 months after RFTC.
Correlations between changes in interictal SEEG-biomarkers (spikes and HFO rates, power spectrum density (PSD), functional connectivity assessed by non-linear correlation coefficient h2) after RFTC versus before RFTC and clinical response (responder vs non responder; percentage change in seizure frequency versus baseline before SEEG) at 3, 6 and 12 months after RFTC.
Measured: From 30 minutes before to 30 minutes after RFTC for SEEG biomarkers; from baseline before SEEG to 3, 6 and 12 months after RFTC for clinical response.
Relationship between changes in blood biomarkers within 72h and 3 months after RFTC and clinical response at 3, 6 and 12 months after RFTC.
Correlation between changes in blood biomarkers (including GFAP, S100b, NFL, UHCL1) within 72 hours and 3 months after RFTC versus before SEEG and clinical response (responder vs non responder; percentage change in seizure frequency versus baseline before SEEG) at 3, 6 and 12 months after RFTC.
Measured: From baseline to 72 hours and 3 months after RFTC for blood biomarkers; from baseline to 3, 6 and 12 months after RFTC (radiofrequency thermocoagulation) for clinical response
Changes in epileptogenicity markers within and outside the Epileptogenic Zone Network (EZN) 24 hours after RFTC
Comparison of omic profiles, specifically ictal epileptogenicity markers EI (Epileptogenicity Index) cEI (connectivity Epileptogenicity Index) and PEI (Permutation Entropy Index) within and outside the Epileptogenic Zone Network (EZN) 24 hours after RFTC
Measured: Within 24 hours after RFTC (during SEEG electrode ablation)
Changes from baseline in the quality of life questionnaire scores at 3-6-12 months after RFTC.
Changes in QOLIE scale (Quality of Life in Epilepsy Inventory-Form 31, 0 to 100, 100 being the best outcome) for adults or EFIQUACCE (its equivalent for children) from baseline, which were assessed before SEEG and at 3, 6, and 12 months after RFTC.
Measured: From baseline before SEEG to 3 months, 6 months and 12 months after RFTC.
To compare between groups the psychiatric impact (depression and anxiety)
Changes between groups of psychiatric comorbidities, specifically depression: score of the NDDI-E (Neurological Disorders Depression Inventory for Epilepsy, 6 to 24, 24 meaning bad outcome), PCL-5 (Post-Traumatic Stress Disorder Checklist for DSM-5, 0 to 52, 52 being the worst outcome) and anxiety: Score of GAD-7 (Generalized Anxiety Disorder - 7, between 0 and 21, 21 meaning bad outcome)
Measured: From baseline before SEEG to 3 months, 6 months and 12 months after RFTC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start19 Jun 2026
- Primary completion31 Jan 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Collaborators
- CRMBM-CEMEREM, UMR 5203, InsermU1191, IGF, Montpellier, Aix Marseille Université
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399327
- Sponsor's protocol ID
- RCAPHM24_0270
- Other IDs
- ID-RCB 2025-A00344-45
- Acronym
- THALPO
- Status last verified
- Jun 2026
- First submitted
- 6 Jan 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Response to SEEG Thermocoagulation in Patients With Refractory Focal Epilepsy
- ClinicalTrials.gov ID
- NCT07399327
- Acronym / sponsor ID
- THALPO / RCAPHM24_0270
- Conditions
- Drug Resistant Epilepsy
- Keywords
- RFTC, Drug resistant epilepsy, SEEG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Collaborators
- CRMBM-CEMEREM, UMR 5203, InsermU1191, IGF, Montpellier, Aix Marseille Université
- Study start
- 19 Jun 2026 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SEEG patients | Experimental | Other: Quality of life questionnaires (QOLIE, EFIQUACEE for children), psychiatric questionnaires (NDDIE, GAD-7, PCL-5) at Visit 1 (V1), V5, V6 and V7, Other: Resting state SEEG recording 30min before and 30 min after RFTC, Other: Blood sample at Visit 1 (V1), V2, V4 and V5, Other: SEEG electrodes tissue-traces sample at V3 (during SEEG electrodes ablation), Other: Multiparametric 3T MRI with gadolinium at V1, V4 and V5, Other: Multiparametric 7T MRI at V1 and V5 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life questionnaires (QOLIE, EFIQUACEE for children), psychiatric questionnaires (NDDIE, GAD-7, PCL-5) at Visit 1 (V1), V5, V6 and V7This intervention consists in the completion of diverse questionnaires assessing the quality of life of the subject. These questionnaires include: * quality of life questionnaires: QOLIE or EFICACEE for children * psychiatric questionnaires NDDIE, GAD-7, PCL-5 These questionnaires will be performed during V1, V5, V6 and V7 | Other | SEEG patients |
| Resting state SEEG recording 30min before and 30 min after RFTCDuring this intervention a resting state SEEG recording will be performed before and after RFTC. These recordings will last for 30 minutes each. | Other | SEEG patients |
| Blood sample at Visit 1 (V1), V2, V4 and V5Blood samples will be collected at Visit 1 (V1), V2, V4 and V5. 2 tubes of 2 ml EDTA will be collected during these visits | Other | SEEG patients |
| SEEG electrodes tissue-traces sample at V3 (during SEEG electrodes ablation)During this intervention, investigators will collect brain tissue samples on SEEG electrodes during their extraction. | Other | SEEG patients |
| Multiparametric 3T MRI with gadolinium at V1, V4 and V53T MRI with gadolinium injections will be performed at V1, V4 and V5. | Other | SEEG patients |
| Multiparametric 7T MRI at V1 and V5Patients will undergo 7T MRI at V1 and V5 | Other | SEEG patients |
Primary outcome
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
Time frame: From baseline before SEEG to 3 months after RFTC
Correlation between changes in the MRI biomarker of BBB permeability (the transfer coefficient, Ki), assessed using 3T MRI before SEEG and 3 months after RFTC and clinical response (responder, non-responder) at 3 months after RFTC.
7 secondary outcomes
Relationship between changes in MRI biomarkers of microstructural damage, large-scale 7T structural connectivity and functional connectivity response at 3 months after RFTC.
Time frame: From baseline before SEEG to 3 months after RFTC.
Relationship between changes in MRI biomarkers of BBB permeability, microstructural damage, large-scale 7T structural connectivity and functional connectivity and clinical response at 6-12 months after RFTC.
Time frame: From baseline before SEEG to 6 months and 12 months after RFTC
Relationship between changes in interictal SEEG-biomarkers (spikes- and HFO rates, power spectrum density (PSD), functional connectivity and clinical response at 3, 6 and 12 months after RFTC.
Time frame: From 30 minutes before to 30 minutes after RFTC for SEEG biomarkers; from baseline before SEEG to 3, 6 and 12 months after RFTC for clinical response.
Relationship between changes in blood biomarkers within 72h and 3 months after RFTC and clinical response at 3, 6 and 12 months after RFTC.
Time frame: From baseline to 72 hours and 3 months after RFTC for blood biomarkers; from baseline to 3, 6 and 12 months after RFTC (radiofrequency thermocoagulation) for clinical response
Changes in epileptogenicity markers within and outside the Epileptogenic Zone Network (EZN) 24 hours after RFTC
Time frame: Within 24 hours after RFTC (during SEEG electrode ablation)
Changes from baseline in the quality of life questionnaire scores at 3-6-12 months after RFTC.
Time frame: From baseline before SEEG to 3 months, 6 months and 12 months after RFTC.
To compare between groups the psychiatric impact (depression and anxiety)
Time frame: From baseline before SEEG to 3 months, 6 months and 12 months after RFTC
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 and Blood sample at Visit 1 (V1), V2, V4 and V5 in people with Drug Resistant Epilepsy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia MAKHALOVA-SCHOLLY (0491384990 ext. 33, Julia.SCHOLLY@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From baseline before SEEG to 3 months after RFTC). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.