Focal EpilepsyEpiMicroNCT04653012
Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients
A study testing Intracranial macro-microelectrode recording in people with Focal Epilepsy and Electrodes, Implanted, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The main goal of this project is to study the mechanisms of epileptic activities using intracranial macro and micro electrodes in epileptic patients undergoing pre-surgical investigation. The recordings will also be used to study physiological mechanisms like sleep and different cognitive functions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Epilepsy, Electrodes, Implanted, Cognitive Function
- What is being tested?
- Intracranial macro-microelectrode recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2021to 27 Feb 2031
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with focal drug-resistant epilepsy
- Patients who undergo a presurgical evaluation with intracranial electrodes in the videoEEG unit of the Neurology department at the Pitié-Salpêtrière hospital.
- Patients who have been informed and provided written informed consent to take part in the study
Who cannot join
- Contraindication for an intracranial investigation (with macro-electrodes) : intercurrent infectious syndrome, decompensated associated pathology (cardiac, pulmonary, renal, hepatic), patient with increased risk of infection (ex: under immunosuppressive therapy)
- Pregnant or parturient woman
- Breastfeeding woman
- Minor person or legally protected adult (tutelage, legal guardianship, maintenance of justice)
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
Hôpital de la Salpêtrière
Paris, 7501F3
Vincent Navarro, Pr, 01 42 16 19 40, vincent.navarro@aphp.fr
About this study
The main goal of this project is to study the mechanisms of epileptic activities using intracranial macro and micro electrodes in epileptic patients undergoing pre-surgical investigation.
The recordings will also be used to study physiological mechanisms like sleep and different cognitive functions.
- Being tested
- Intracranial macro-microelectrode recording
- Keywords
- Microelectrodes, Seizures, EEG
- Medical subject headings
- Epilepsies, Partial, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracranial macro-microelectrode recordingDevice
Additionnally to clinical macroelectrodes, Benkhe-Fried depth macro-microelectrodes will be implanted and recorded during the pre-surgical investigation of epileptic patients
| Study group | Role | What they receive |
|---|---|---|
| Macro-microelectrode implantation | Experimental | Implantation of macro-micro electrodes of the Adtech Benkhe-Fried type in epileptic patients who are undergoing evaluation with intracranial EEG electrodes Receives: Device: Intracranial macro-microelectrode recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of single unit changes at seizure emergence
In order to identify biomarkers of epileptic seizures we will study single neuron activities (firing rate) using spike sorting at different time periods (before, during and after seizures and during interictal periods)
We expect to observe significant changes in firing rate across the different time periods.
Measured: Whole duration of the clinical inverstigation, until 4 weeks
Identification of local field potential (LFP) changes at seizure emergence
In order to identify biomarkers of epileptic seizures we will study LFP power using time frequency analysis at different time periods (before, during and after seizures and during interictal periods)
We expect to observe significant changes in LFP power across the different time periods.
Measured: Whole duration of the clinical inverstigation, until 4 weeks
Secondary outcomes (4)
Comparison of single unit activity before seizure according to brain localization
We will compare firing rate before seizure according to brain regions (anatomy and involvement in the seizure onset zone)
Measured: Whole duration ofthe clinical inverstigation, until 4 weeks
Identification of single unit changes during physiological brain activity
We will compare firing rates during resting states and stimulus induced states.
We expect to observe significant changes in firing rate between states.
Measured: Whole duration ofthe clinical inverstigation, until 4 weeks
Identification of LFP power changes during physiological brain activity
We will compare LFP power during resting states and stimulus induced states.
We expect to observe significant changes in LFP power between states.
Measured: Whole duration ofthe clinical inverstigation, until 4 weeks
Multilevel study of brain activity
We will look for correlation between firing rates and LFP power changes.
Measured: Whole duration ofthe clinical inverstigation, until 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start28 Feb 2021
- Primary completion27 Feb 2029 (estimated)
- Study completion27 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653012
- Sponsor's protocol ID
- C19-55
- Other IDs
- 2020-A00445-34
- Acronym
- EpiMicro
- Status last verified
- Sep 2026
- First submitted
- 5 Nov 2020
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients
- ClinicalTrials.gov ID
- NCT04653012
- Acronym / sponsor ID
- EpiMicro / C19-55
- Keywords
- Microelectrodes, Seizures, EEG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 27 Feb 2029 (estimated)
- Study completion
- 27 Feb 2031 (estimated)
- First posted
- 4 Dec 2020 (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.
The main goal of this project is to study the mechanisms of epileptic activities using intracranial macro and micro electrodes in epileptic patients undergoing pre-surgical investigation.
The recordings will also be used to study physiological mechanisms like sleep and different cognitive functions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Macro-microelectrode implantation | Experimental | Device: Intracranial macro-microelectrode recordingImplantation of macro-micro electrodes of the Adtech Benkhe-Fried type in epileptic patients who are undergoing evaluation with intracranial EEG electrodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with focal drug-resistant epilepsy
- Patients who undergo a presurgical evaluation with intracranial electrodes in the videoEEG unit of the Neurology department at the Pitié-Salpêtrière hospital.
- Patients who have been informed and provided written informed consent to take part in the study
Key exclusion criteria (4 listed)
- Contraindication for an intracranial investigation (with macro-electrodes) : intercurrent infectious syndrome, decompensated associated pathology (cardiac, pulmonary, renal, hepatic), patient with increased risk of infection (ex: under immunosuppressive therapy)
- Pregnant or parturient woman
- Breastfeeding woman
- Minor person or legally protected adult (tutelage, legal guardianship, maintenance of justice)
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 |
|---|---|---|
| Intracranial macro-microelectrode recordingAdditionnally to clinical macroelectrodes, Benkhe-Fried depth macro-microelectrodes will be implanted and recorded during the pre-surgical investigation of epileptic patients | Device | Macro-microelectrode implantation |
Primary outcome
Identification of single unit changes at seizure emergence
Time frame: Whole duration of the clinical inverstigation, until 4 weeks
In order to identify biomarkers of epileptic seizures we will study single neuron activities (firing rate) using spike sorting at different time periods (before, during and after seizures and during interictal periods) We expect to observe significant changes in firing rate across the different time periods.
Identification of local field potential (LFP) changes at seizure emergence
Time frame: Whole duration of the clinical inverstigation, until 4 weeks
In order to identify biomarkers of epileptic seizures we will study LFP power using time frequency analysis at different time periods (before, during and after seizures and during interictal periods) We expect to observe significant changes in LFP power across the different time periods.
4 secondary outcomes
Comparison of single unit activity before seizure according to brain localization
Time frame: Whole duration ofthe clinical inverstigation, until 4 weeks
Identification of single unit changes during physiological brain activity
Time frame: Whole duration ofthe clinical inverstigation, until 4 weeks
Identification of LFP power changes during physiological brain activity
Time frame: Whole duration ofthe clinical inverstigation, until 4 weeks
Multilevel study of brain activity
Time frame: Whole duration ofthe clinical inverstigation, until 4 weeks
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 28 Sep 2026.
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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 Intracranial macro-microelectrode recording in people with Focal Epilepsy and Electrodes, Implanted, run by Institut National de la Santé Et de la Recherche Médicale, France 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 3 inclusion and 4 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 28 Sep 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 Vincent Navarro (01 42 16 19 40, vincent.navarro@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of single unit changes at seizure emergence (time frame: Whole duration of the clinical inverstigation, until 4 weeks). The study lists 2 primary outcomes in all. 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 28 Sep 2026.