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Recruiting NCT04653012

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

No phase Interventional Focal Epilepsy Electrodes, Implanted Cognitive Function Neurophysiology

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intracranial macro-microelectrode recording.
Who it may be relevant to
Registry conditions: Focal Epilepsy, Electrodes, Implanted, Cognitive Function, Neurophysiology. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Device Intracranial 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

Primary outcome measures

  • Identification of single unit changes at seizure emergence [Time frame: Whole duration of the clinical inverstigation, until 4 weeks]
  • Identification of local field potential (LFP) changes at seizure emergence [Time frame: Whole duration of the clinical inverstigation, until 4 weeks]
Secondary outcome measures (4)
  • 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]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Hôpital de la Salpêtrière — Paris

Identifiers

NCT: NCT04653012 · C19-55 · 2020-A00445-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗