CClinicalTrials.gg
RecruitingNCT04653012EpiMicroUpdated Sep 28, 2026

Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients

An interventional study of Intracranial macro-microelectrode recording in Focal Epilepsy, Electrodes, Implanted and Cognitive Function, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Focal Epilepsy
  • Electrodes, Implanted
  • Cognitive Function
  • Neurophysiology

Keywords

  • Microelectrodes
  • Seizures
  • EEG
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Macro-microelectrode implantation

    Implantation of macro-micro electrodes of the Adtech Benkhe-Fried type in epileptic patients who are undergoing evaluation with intracranial EEG electrodes

    Device: Intracranial macro-microelectrode recording

Interventions

  • DeviceIntracranial macro-microelectrode recording

    Additionnally to clinical macroelectrodes, Benkhe-Fried depth macro-microelectrodes will be implanted and recorded during the pre-surgical investigation of epileptic patients

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Whole duration of the clinical inverstigation, until 4 weeks

  2. 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.

    Time frame: Whole duration of the clinical inverstigation, until 4 weeks

Secondary outcomes

  1. 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)

    Time frame: Whole duration ofthe clinical inverstigation, until 4 weeks

  2. 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.

    Time frame: Whole duration ofthe clinical inverstigation, until 4 weeks

  3. 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.

    Time frame: Whole duration ofthe clinical inverstigation, until 4 weeks

  4. Multilevel study of brain activity

    We will look for correlation between firing rates and LFP power changes.

    Time frame: Whole duration ofthe clinical inverstigation, until 4 weeks

06

Study locations

1 of 1 sites recruiting
  • Hôpital de la Salpêtrière
    Paris, 7501F3, France
    Recruiting
07

Registry details

Key details

Study ID
NCT04653012
Lead sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Dec 4, 2020
Start date
Feb 28, 2021
Primary completion
Feb 27, 2029 (estimated)
Completion
Feb 27, 2031 (estimated)
Last update
Sep 28, 2026

Study contacts

Vincent Navarro
Contact
vincent.navarro@aphp.fr
01 42 16 19 40
Virginie Lambrecq
Contact
Virginie.lambrecq@aphp.fr
0142161572

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion