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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04653012
Acronym
EpiMicro
Enrollment
50
Registered
2020-12-04
Start date
2021-02-28
Completion date
2031-02-27
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Function, Electrodes, Implanted, Focal Epilepsy, Neurophysiology

Keywords

Microelectrodes, Seizures, EEG

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.

Interventions

DEVICEIntracranial 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

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Identification of single unit changes at seizure emergenceWhole duration of the clinical inverstigation, until 4 weeksIn 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 emergenceWhole duration of the clinical inverstigation, until 4 weeksIn 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

MeasureTime frameDescription
Comparison of single unit activity before seizure according to brain localizationWhole duration ofthe clinical inverstigation, until 4 weeksWe 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 activityWhole duration ofthe clinical inverstigation, until 4 weeksWe 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 activityWhole duration ofthe clinical inverstigation, until 4 weeksWe 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 activityWhole duration ofthe clinical inverstigation, until 4 weeksWe will look for correlation between firing rates and LFP power changes.

Countries

France

Contacts

Primary ContactVincent Navarro
vincent.navarro@aphp.fr01 42 16 19 40
Backup ContactVirginie Lambrecq
Virginie.lambrecq@aphp.fr0142161572

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026