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

Cognitive Function Clinical Trial

— EpiMicro  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04653012
• Other study ID #: C19-55
• Secondary ID: 2020-A00445-34
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2030

Study information

• Verified date: October 2020
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Vincent Navarro
• Phone: 01 42 16 19 40
• Email: vincent.navarro[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2030
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Function
• Electrodes, Implanted
• Epilepsies, Partial
• Focal Epilepsy
• Neurophysiology

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Whole duration of the clinical inverstigation, until 4 weeks
Primary	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.	Whole duration of the clinical inverstigation, until 4 weeks
Secondary	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)	Whole duration ofthe clinical inverstigation, until 4 weeks
Secondary	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.	Whole duration ofthe clinical inverstigation, until 4 weeks
Secondary	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.	Whole duration ofthe clinical inverstigation, until 4 weeks
Secondary	Multilevel study of brain activity	We will look for correlation between firing rates and LFP power changes.	Whole duration ofthe clinical inverstigation, until 4 weeks