EpilepsyNENUFARNCT06105645
Contribution of Fast-ripples to the Improvement of the Neurosurgical Management of Drug-refractory Epilepsy
A study testing DIXI Medical Microdeep® Micro- Macro Depth electrodes and Standard electrodes in people with Epilepsy, run by University Hospital, Toulouse at 12 sites in France.
Trial summary
The main aim of this study is to evaluate the contribution of fast-ripples (FR) information on the neurosurgery management of patients with drug-refractory epilepsy investigated by Stereo-ElectroEncephaloGraphy (SEEG), as measured by freedom from disabling seizures one-year post-surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- DIXI Medical Microdeep® Micro- Macro Depth electrodes and Standard electrodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 12 sitesFrance
- Study dates
- 19 Jan 2024to Apr 2030
- Phase
- Interventional
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient suffering from drug-resistant focal epilepsy (DRFE), as defined by the International League Against Epilepsy, undergoing SEEG, the indication of which was selected during a multidisciplinary epilepsy meeting
- Patient who has given written informed consent to allow the study data collection procedures
- Patient covered by the French healthcare system.
Who cannot join
- Patients under juridical protection (authorship, curators or safeguarding of justice).
- Patient deprived of liberty by a judicial or administrative decision
- Patient with a cardiac defibrillator
- Patient in exclusion period of another study.
- No other non-inclusion criteria since the study will only be proposed to patients who already meet the criteria for a SEEG
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yoan HERADES contact
12 sites in 1 country
France12 sites, 12 recruiting
- Recruiting
CHU Amiens Picardie
Amiens
William SZURHAJ
William SZURHAJ
- Recruiting
University hospital of Bordeaux
Bordeaux, 33076
Véronique MICHEL
Véronique MICHEL
- Recruiting
University hospital of Grenoble Alpes
La Tronche, 38700
Philippe KAHANE
Philippe KAHANE
- Recruiting
APHP Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270
Delphine TAUSSIG
Dephine TAUSSIG
- Recruiting
CHU de Lille
Lille
Philippe DERAMBURE
Philippe DERAMBURE
- Recruiting
Hospices Civils de Lyon
Lyon
Sylvain RHEIMS
Sylvain RHEIMS
- Recruiting
CHRU de Nancy
Nancy
Jacques JONAS
Jacques JONAS
- Recruiting
Hôpital Pitié Salpêtrière
Paris, 75013
Vincent NAVARRO
Vincent NAVARRO
- Recruiting
Fondation Adolphe de Rothschild
Paris, 75019
Sinéad ZEIDAN
Sinéad ZEIDAN
- Recruiting
CHU de Rennes
Rennes
Dragos-Mihai MALIIA
Dragos-Mihai MALIIA
- Recruiting
Hôpitaux universitaires de Strasbourg
Strasbourg
Edouard HIRSCH
Edouard HIRSCH
- Recruiting
University Hospital of Toulouse
Toulouse, 31059
Luc VALTON, MD, 0561775608, valton.l@chu-toulouse.fr
Yoan HERADES, yoan.herades@inserm.fr
About this study
The main aim of this study is to evaluate the contribution of fast-ripples (FR) information on the neurosurgery management of patients with drug-refractory epilepsy investigated by Stereo-ElectroEncephaloGraphy (SEEG), as measured by freedom from disabling seizures one-year post-surgery.
220 patients (for whom 4-6 usual clinical macro-electrodes will be replaced by hybrid micro-macro electrodes and for whom fast-ripples will be assessed) distributed over 6 centres and 220 control patients(who will undergo an SEEG with the usual electrodes and for whom fast-ripples will not be assessed) distributed over 6 centres. This is a controlled, non-randomized, parallel plan, prospective, multicentre exploratory study.
Read the detailed description
This is a controlled, non-randomized, parallel plan, prospective, multicentre exploratory study. The design of the study relies on two groups of patients benefiting from a SEEG, equivalent in size: one with standard and hybrid electrodes for which fast-ripple information will be available for the neurosurgery decision, the other, who will serve as a control group, with standard electrodes only and for which no information regarding fast-ripples will be provided. For all patients undergoing SEEG, the decisions about eligibility to epilepsy surgery and, if eligible, about the best surgical plan, are taken during a multidisciplinary epilepsy meeting (MEM) within the 4 +/- 2 months following the SEEG. In the group of patients with standard and hybrid electrodes, the procedure as extensively tested previously, is to plan the implantation of the standard electrodes as usually done, and once done, to replace from 4 to 6 standard electrodes with hybrid electrodes. In this group, intracerebral ElectroEncephaloGraphy (EEG) data will be acquired for detection of fast-ripples, during one hour of a rest period for 2 days during the first week of SEEG, as well as during one cycle of night sleep when possible. Fast-ripples(number, localization and characteristics) for all these patients will be analysed by an expert group of neuroscientists based in Toulouse blind to the analysis of the Epileptogenic Zone (EZ), irritative and propagation zones and on all micro- and macro contacts, to the participating centre and to the period of recording. The results of the fast-ripple assessment will be provided to the clinicians on time for the MEM. They will incorporate this information along other usual clinical information gathered during the SEEG to reach a conclusion regarding the possibility of a neurosurgery. No analysis of the fast-ripples will be performed in the other group of patients with standard electrodes only. In this group, the conclusion regarding the possibility of a neurosurgery will thus be done during the MEM with the standard clinical information gathered during the SEEG only. Following epilepsy surgery, the typical follow-up performed in routine in all participating centres includes a clinical evaluation one year after surgery, during which Engel class is assessed.
- Conditions
- Epilepsy
- Being tested
- DIXI Medical Microdeep® Micro- Macro Depth electrodes, Standard electrodes
- Keywords
- Fast-ripples, Epilepsy, Neurosurgery, Hybrid electrodes, MICRODEEP® MME hybrid electrodes, StereoEEG
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DIXI Medical Microdeep® Micro- Macro Depth electrodesDevice
It is a deep intracerebral electrode used in the pre-surgical diagnosis of certain drug-resistant epilepsies. It consists of micro- and macro-contacts and is designed for Stereo-ElectroEncephalography (SEEG) recording via the macro-contacts or micro-contacts and brief stimulation via the macro-contacts.
Standard electrodesDevice
Standard electrodes used usually during the SEEG
| Study group | Role | What they receive |
|---|---|---|
| Arm with fast-ripples information | Experimental | Patients for whom 4-6 usual clinical macro-electrodes will be replaced by hybrid micro-macro electrodes and for whom fast-ripples will be assessed Receives: Device: DIXI Medical Microdeep® Micro- Macro Depth electrodes |
| Arm without fast-ripples information | Active comparator | Patients who will undergo an SEEG with the usual electrodes and for whom fast-ripples will not be assessed. Receives: Device: Standard electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contribution of fast-ripples information on freedom seizures
Proportion of patients with Engel class I after one-year post-surgery in the group of patients with information of fast-ripples compared to patients without.
Measured: 12 months after epilepsy surgery
Secondary outcomes (14)
Contribution of fast-ripples information on improvement of epilepsy
Proportion of patients with Engel classes I to III one-year post-surgery of patients with information of fast-ripples compared to patients without.
Measured: 12 months after epilepsy surgery
Contribution of fast-ripples information on patients addressed to neurosurgery
Proportion of patients operated for their epilepsy in the group of patients with information of fast-ripples compared to patients without.
Measured: 12 months after epilepsy surgery
Adverse effects related to Stereo-electroencephalography
Quantitative and qualitative description of adverse effects related to the Stereo-electroencephalography (SEEG) in the group of patients with information of fast-ripples compared to patients without.
Measured: Day 0 (SEEG visit)
Adverse effects of epilepsy surgery
Quantitative and qualitative description of adverse effects related to epilepsy surgery in the group of patients with information of fast-ripples compared to patients without.
Measured: 6 months after surgical decision
Adverse effects of hybrid electrodes
Quantitative and qualitative description of adverse effects related to the hybrid electrodes.
Measured: Day 0 (SEEG visit)
Post-operative neurological deficit
Number of patients suffering from disabling post-operative neurological deficit, anxiety or depression in the group of patients with information of fast-ripples versus patients without
Measured: 12 months after epilepsy surgery
Evolution of quality of life using the score of Quality of life Epilepsy Inventory Epilepsy Inventory
Delta of quality of life using the score of Quality of life Epilepsy Inventory (QOLIE-31) between baseline and 12 months related to epilepsy surgery in the group of patients with information of fast-ripples compared to patients without.
QOLIE-31 is a 31-item questionnaire with different proposal scores. The maximal total score is 100 : the higher the score, the better the quality of life
Measured: 12 months after epilepsy surgery
Level of satisfaction
Mean of level of satisfaction with the outcome of epilepsy surgery assessed using the Evaluation of changes in daily life after epilepsy surgery (EVOCQUE) self-questionnaire, 12 months after surgery, related to epilepsy surgery in the group of patients with information of fast-ripples compared to patients without.
EVOCQUE is a self-questionnaire with ten different questions and proposal scores.
Measured: 12 months after epilepsy surgery
Recording of fast-ripples
Number of fast-ripples recorded on the hybrid electrodes, on the one hand on the micro- contacts and on the other hand on the adjacent macro-contacts of the same hybrid electrode.
Measured: Day 0 (SEEG visit)
Distribution of the fast-ripples
Number of fast-ripples in the Epileptogenic Zone, Irritative Zone and healthy zone
Measured: Day 0 (SEEG visit)
Number of fast-ripples recorded according to the period
Number of fast-ripples recorded during one period of sleep, an equivalent period of nap and an equivalent period of sitcom watching.
Measured: Day 0 (SEEG visit)
Contribution of using an Epileptogenicity Index
Proportion of patients in Engel class I at one year after surgery among those whose epileptogenic zone was evaluated using an Epileptogenicity Index vs those whose epileptogenic zone was not evaluated using an Epileptogenicity Index in the group of patients with FR information and in the group of patients without FR information.
Measured: 12 months after epilepsy surgery
Impact of RF-TC (Radiofrequency- Thermocoagulation) by SEEG on epilepsy at 4 months
Proportion of seizure-free patients at 4 and 10 months post- SEEG (visits 3 and 4), among patients who underwent SEEG based RF-TC in the group of patients with FR information and in the group of patients without FR information.
Measured: Visit 3 : 4 months post-SEEG
Impact of RF-TC (Radiofrequency- Thermocoagulation) by SEEG on epilepsy at 10 months
Proportion of seizure-free patients at 10 months post- SEEG (visit 4), among patients who underwent SEEG based RF-TC in the group of patients with FR information and in the group of patients without FR information.
Measured: Visit 4 : 10 months post-SEEG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start19 Jan 2024
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de recherche Cerveau et Cognition (CERCO), Dixi Medical
- Responsible party
- Sponsor
- Investigators
- Luc VALTON, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105645
- Sponsor's protocol ID
- RC31/22/0260
- Other IDs
- 2022-A02552-41
- Acronym
- NENUFAR
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Despouy E, Curot J, Reddy L, Nowak LG, Deudon M, Sol JC, Lotterie JA, Denuelle M, Maziz A, Bergaud C, Thorpe SJ, Valton L, Barbeau EJ. Recording local field potential and neuronal activity with tetrodes in epileptic patients. J Neurosci Methods. 2020 Jul 15;341:108759. doi: 10.1016/j.jneumeth.2020.108759. Epub 2020 May 7.
PubMed 32389603