EpilepsyEpi-FaRNCT02491476
Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy
A study testing intracerebral micro-macroelectrodes in people with Epilepsy, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The main objective of this study is to evaluate the feasibility of recording fast-ripples, a potential new biomarker of epilepsy, using the new micro-macroelectrodes developed by Dixi-Medical. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- intracerebral micro-macroelectrodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2015to 18 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient with RPE in whom SEEG is required to precisely localize the seizure focus
Who cannot join
- Patients with SEEG contra-indication:
- severe psychiatric disorders,
- severe agitation during their crisis
- contraindication for performing an MRI: claustrophobia, a cardiac or neural stimulator, ferromagnetic surgical clips, cochlear implants, intraocular metallic foreign body or in the nervous system,
- contraindication to intracerebral investigation (macro-electrodes): ongoing infection, severe associated pathology (cardiac, pulmonary, renal, hepatic), pregnant or nursing women,
- anti thrombotic ongoing treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Interest of Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy
The main objective of this study is to evaluate the feasibility of recording fast-ripples, a potential new biomarker of epilepsy, using the new micro-macroelectrodes developed by Dixi-Medical.
Read the detailed description
Partial epilepsies are refractory to medical treatment in 30% of the cases (Refractory Partial Epilepsy or RPE). Patients with RPE suffer from social and occupational disability, an increased risk associated with seizures (traumatic brain injury, accidents), but also a higher risk of sudden unexplained death (2 to 3 times higher) than the general population. Moreover, the medical and social burden of these patients is heavy, representing a significant cost to society.
In some cases, surgical treatment with resection of the epileptogenic zone (EZ) can be proposed. The presurgical evaluation includes various investigations seeking to clarify the location of the EZ; but this approach is sometimes insufficient and the definition of the EZ then requires invasive exploration through intracerebral EEG recording (stereo-EEG, SEEG). This latter technique is currently the preferred standard to define the EZ. It involves implanting electrodes in the brain areas suspected to belong to the seizure network. 50 to 70% of patients investigated with this technique will have epilepsy surgery.
In recent years, a series of studies in animals and humans have suggested that some oscillations, very short and at very high frequency (> 250 Hz), called "fast ripples" (FRs) could be a good biomarker of the EZ (for a review see Zijlmans et al, 2012). The FRs are more easily recorded from microelectrode (diameter: 20-40 microns).
The purpose of this study is to evaluate a new medical device designed by DixiMedical to record FRs, combining micro and regular clinical electrodes.
- Conditions
- Epilepsy
- Being tested
- intracerebral micro-macroelectrodes
- Keywords
- Safety, Electrodes, Device, StereoElectroencephalograph, Epileptogenic zone, Fast ripples
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intracerebral micro-macroelectrodesDevice
All patients will be implanted with usually 4 micro-macroelectrodes (replacing the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed.
| Study group | Role | What they receive |
|---|---|---|
| micro-macroelectrodes | Experimental | All patients will be implanted with usually 4 intracerebral micro-macroelectrodes(replacing the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed. Receives: Device: intracerebral micro-macroelectrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the feasibility of recording Fast Ripples (FRs)
Proportion of patients who are registered more than 60 FRs per hour the day 3 and the day 4 on the micro-macro electrode in the presumed epileptogenic zone, compared to the number of patients included
Measured: During 5 days
Secondary outcomes (4)
Evaluation of the interest of FRs
Sum of FRs recorded over the 5 days.
Measured: During 5 days
Evolution of the hourly frequency of FRs
The evolution of the hourly frequency of FRs recorded by the microelectrodes depending on the day of recording.
Measured: During 5 days
Effectiveness of microelectrodes and macroelectrodes
Number of FRs stored on the macro-blocks immediately adjacent to the microelectrodes located in the EZ.
Measured: During 5 days
safety of micro-macroelectrodes
A quantitative and qualitative description of the side effects associated with the procedure.
Measured: During 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startMar 2015
- Primary completion18 Aug 2022
- Study completion18 Sep 2022
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- CerCo, CNRS Cerco UMR5549 CHU Purpan Toulouse France, DIXI Medical, Besançon, France
- Responsible party
- Sponsor
- Investigators
- luc valton, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02491476
- Sponsor's protocol ID
- RC31/13/6899
- Other IDs
- 2014-A00747-40
- Acronym
- Epi-FaR
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2015
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Despouy E, Curot J, Denuelle M, Deudon M, Sol JC, Lotterie JA, Reddy L, Nowak LG, Pariente J, Thorpe SJ, Valton L, Barbeau EJ. Neuronal spiking activity highlights a gradient of epileptogenicity in human tuberous sclerosis lesions. Clin Neurophysiol. 2019 Apr;130(4):537-547. doi: 10.1016/j.clinph.2018.12.013. Epub 2019 Jan 30.
PubMed 30785010
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Interest of Recording "Fast Ripples" Using Microelectrodes During Stereo-encephalography in Patients With Drug-resistant Partial Epilepsy
- ClinicalTrials.gov ID
- NCT02491476
- Acronym / sponsor ID
- Epi-FaR / RC31/13/6899
- Conditions
- Epilepsy
- Keywords
- Safety, Electrodes, Device, StereoElectroencephalograph, Epileptogenic zone, Fast ripples
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- CerCo, CNRS Cerco UMR5549 CHU Purpan Toulouse France, DIXI Medical, Besançon, France
- Study start
- Mar 2015 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Sep 2022 (actual)
- First posted
- 8 Jul 2015 (estimated)
- 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.
The main objective of this study is to evaluate the feasibility of recording fast-ripples, a potential new biomarker of epilepsy, using the new micro-macroelectrodes developed by Dixi-Medical.
Detailed description
Partial epilepsies are refractory to medical treatment in 30% of the cases (Refractory Partial Epilepsy or RPE). Patients with RPE suffer from social and occupational disability, an increased risk associated with seizures (traumatic brain injury, accidents), but also a higher risk of sudden unexplained death (2 to 3 times higher) than the general population. Moreover, the medical and social burden of these patients is heavy, representing a significant cost to society.
In some cases, surgical treatment with resection of the epileptogenic zone (EZ) can be proposed. The presurgical evaluation includes various investigations seeking to clarify the location of the EZ; but this approach is sometimes insufficient and the definition of the EZ then requires invasive exploration through intracerebral EEG recording (stereo-EEG, SEEG). This latter technique is currently the preferred standard to define the EZ. It involves implanting electrodes in the brain areas suspected to belong to the seizure network. 50 to 70% of patients investigated with this technique will have epilepsy surgery.
In recent years, a series of studies in animals and humans have suggested that some oscillations, very short and at very high frequency (> 250 Hz), called "fast ripples" (FRs) could be a good biomarker of the EZ (for a review see Zijlmans et al, 2012). The FRs are more easily recorded from microelectrode (diameter: 20-40 microns).
The purpose of this study is to evaluate a new medical device designed by DixiMedical to record FRs, combining micro and regular clinical electrodes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| micro-macroelectrodes | Experimental | Device: intracerebral micro-macroelectrodesAll patients will be implanted with usually 4 intracerebral micro-macroelectrodes(replacing the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed. |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with RPE in whom SEEG is required to precisely localize the seizure focus
Key exclusion criteria (6 listed)
- severe psychiatric disorders,
- severe agitation during their crisis
- contraindication for performing an MRI: claustrophobia, a cardiac or neural stimulator, ferromagnetic surgical clips, cochlear implants, intraocular metallic foreign body or in the nervous system,
- contraindication to intracerebral investigation (macro-electrodes): ongoing infection, severe associated pathology (cardiac, pulmonary, renal, hepatic), pregnant or nursing women,
- anti thrombotic ongoing treatment.
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 |
|---|---|---|
| intracerebral micro-macroelectrodesAll patients will be implanted with usually 4 micro-macroelectrodes (replacing the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed. | Device | micro-macroelectrodes |
Primary outcome
Evaluation of the feasibility of recording Fast Ripples (FRs)
Time frame: During 5 days
Proportion of patients who are registered more than 60 FRs per hour the day 3 and the day 4 on the micro-macro electrode in the presumed epileptogenic zone, compared to the number of patients included
4 secondary outcomes
Evaluation of the interest of FRs
Time frame: During 5 days
Evolution of the hourly frequency of FRs
Time frame: During 5 days
Effectiveness of microelectrodes and macroelectrodes
Time frame: During 5 days
safety of micro-macroelectrodes
Time frame: During 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 30785010Despouy E, Curot J, Denuelle M, Deudon M, Sol JC, Lotterie JA, Reddy L, Nowak LG, Pariente J, Thorpe SJ, Valton L, Barbeau EJ. Neuronal spiking activity highlights a gradient of epileptogenicity in human tuberous sclerosis lesions. Clin Neurophysiol. 2019 Apr;130(4):537-547. doi: 10.1016/j.clinph.2018.12.013. Epub 2019 Jan 30.
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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. This study is not recruiting at the moment.
luc valton, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intracerebral micro-macroelectrodes in people with Epilepsy, run by University Hospital, Toulouse 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 1 inclusion and 6 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: finished, as of the sponsor's last update on 6 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the feasibility of recording Fast Ripples (FRs) (time frame: During 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02491476, which also lists 1 linked publication.
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 6 May 2026.