search
Back to results

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

Primary Purpose

Focal Epilepsy, Electrodes, Implanted, Cognitive Function

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intracranial macro-microelectrode recording
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Focal Epilepsy focused on measuring Microelectrodes, Seizures, EEG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Macro-microelectrode implantation

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    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)
    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.
    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.
    Multilevel study of brain activity
    We will look for correlation between firing rates and LFP power changes.

    Full Information

    First Posted
    November 5, 2020
    Last Updated
    November 25, 2020
    Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04653012
    Brief Title
    Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients
    Acronym
    EpiMicro
    Official Title
    Multi-level Approach of Brain Activity Using Intracranial Electrodes in Epileptic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2020 (Anticipated)
    Primary Completion Date
    December 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2030 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut National de la Santé Et de la Recherche Médicale, France

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Focal Epilepsy, Electrodes, Implanted, Cognitive Function, Neurophysiology
    Keywords
    Microelectrodes, Seizures, EEG

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Macro-microelectrode implantation
    Arm Type
    Experimental
    Arm Description
    Implantation of macro-micro electrodes of the Adtech Benkhe-Fried type in epileptic patients who are undergoing evaluation with intracranial EEG electrodes
    Intervention Type
    Device
    Intervention Name(s)
    Intracranial macro-microelectrode recording
    Intervention Description
    Additionnally to clinical macroelectrodes, Benkhe-Fried depth macro-microelectrodes will be implanted and recorded during the pre-surgical investigation of epileptic patients
    Primary Outcome Measure Information:
    Title
    Identification of single unit changes at seizure emergence
    Description
    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
    Title
    Identification of local field potential (LFP) changes at seizure emergence
    Description
    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 Outcome Measure Information:
    Title
    Comparison of single unit activity before seizure according to brain localization
    Description
    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
    Title
    Identification of single unit changes during physiological brain activity
    Description
    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
    Title
    Identification of LFP power changes during physiological brain activity
    Description
    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
    Title
    Multilevel study of brain activity
    Description
    We will look for correlation between firing rates and LFP power changes.
    Time Frame
    Whole duration ofthe clinical inverstigation, until 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vincent Navarro
    Phone
    01 42 16 19 40
    Email
    vincent.navarro@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Virginie Lambrecq
    Phone
    0142161572
    Email
    Virginie.lambrecq@aphp.fr

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs