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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut National de la Santé Et de la Recherche Médicale, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Macro-microelectrode implantationExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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