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Clinical Trials/NCT04653012
NCT04653012
Recruiting
Not Applicable

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

Institut National de la Santé Et de la Recherche Médicale, France1 site in 1 country50 target enrollmentFebruary 28, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Focal Epilepsy
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Enrollment
50
Locations
1
Primary Endpoint
Identification of single unit changes at seizure emergence
Status
Recruiting
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 28, 2021
End Date
February 27, 2031
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Identification of single unit changes during physiological brain activity(Whole duration ofthe clinical inverstigation, until 4 weeks)
  • Identification of LFP power changes during physiological brain activity(Whole duration ofthe clinical inverstigation, until 4 weeks)
  • Multilevel study of brain activity(Whole duration ofthe clinical inverstigation, until 4 weeks)
  • Comparison of single unit activity before seizure according to brain localization(Whole duration ofthe clinical inverstigation, until 4 weeks)

Study Sites (1)

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