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NCT Number: NCT04653012

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

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.

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Key information

Conditions

Focal Epilepsy Brain Diseases Central Nervous System Diseases Cognitive Function Electrodes, Implanted Epilepsies, Partial Epilepsy Nervous System Diseases Neurologic Manifestations Neurophysiology Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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)

Treatment and study plan

Intracranial macro-microelectrode recording

Device

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Comparison of single unit activity before seizure according to brain localization

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

    We will compare firing rate before seizure according to brain regions (anatomy and involvement in the seizure onset zone)

  2. Identification of single unit changes during physiological brain activity

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

    We will compare firing rates during resting states and stimulus induced states.

    We expect to observe significant changes in firing rate between states.

  3. Identification of LFP power changes during physiological brain activity

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

    We will compare LFP power during resting states and stimulus induced states.

    We expect to observe significant changes in LFP power between states.

  4. Multilevel study of brain activity

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Vincent Navarro

CONTACT

[email protected]

01 42 16 19 40

Virginie Lambrecq

CONTACT

[email protected]

0142161572

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Registry information

Acronym: EpiMicro

Important dates

Study start
2021
Primary completion
2029
Study completion
2031
First posted
Dec 4, 2020
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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