Brain Activity in Epilepsy

Not Applicable

Recruiting

• Conditions: Epilepsy
• Interventions: Device: macro/micro electrode recording

• Registration Number: NCT05307146
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

Prospective interventional study with implantation of micro-electrodes to study the brain networks in epilepsy at high spatiotemporal resolution.

Detailed Description

The goal of this trial is to study brain activity in epilepsy at high spatiotemporal resolution. Apart from the epileptogenic network (dysfunctional areas), the investigators will study human brain function.

The use of micro-electrode arrays allows to study the human brain a high spatiotemporal resolution, even at the single neuron level.

Scientific objectives of the current project:

* To record neural signals from macro-electrodes and delineate the epileptogenic network and study brain function during specific tasks.

* To record neural signals from micro-electrodes and delineate the epileptogenic network and study brain function during specific tasks.

* Identifying pivotal regions for BMI applications and developing online decoding algorithms.

* Comparing neural recordings to fMRI activity

Study Timeline

• Study Start: 2013-12-18
• Study First Submitted: 2019-01-18
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-22
• Last Update Submitted: 2022-03-22
• Study First Posted: 2022-04-01
• Last Update Posted: 2022-04-01
• Primary Completion: 2035-01-01
• Study Completion: 2035-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age ≥18 yo
• Epilepsy patients undergoing intracranial electrode placement.
• Able to understand the procedure involved and to consent.

Exclusion Criteria

• Age < 18 yo
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
micro/macro electrode	macro/micro electrode recording	-

Primary Outcome Measures

Name	Time	Method
Electrophysiological recordings: single neuron recordings	15 years	The investigators will investigate the epileptogenic network by recording neural activity at different spatiotemporal scales and using different modalities. The investigators will be looking at \* Electrophysiological recordings: - single neuron recordings (outcome measure: spike rate)
Electrophysiological recordings: LFP	15 years	The investigators will investigate the epileptogenic network by recording neural activity at different spatiotemporal scales and using different modalities. The investigators will be looking at \* Electrophysiological recordings: - local field potentials (LFP) (outcome measure: mainly power in the beta and gamma band, but also alfa and theta band)
fMRI recordings	15 years	\* fMRI recordings (outcome measure: Blood Oxygen Level Dependent (BOLD) signal increases/decreases); By performing electrophysiological recordings and fMRI recordings in the same subjects, we will be able to compare both modalities with each other.

Secondary Outcome Measures

Name	Time	Method
Neurophysiological study of different brain areas: power gamma band	15 years	Since electrodes are placed for clinical purposes, the investigators will also use these electrodes to investigate normal neural functions of the human brain: vision, perception and motor.; \* Macro-electrodes record local field potentials (LFP). The main outcome measure for visual research is the power in the gamma band. The main outcome measure for motor research is power increase in the beta and gamma band.
Neurophysiological study of different brain areas: spike activity	15 years	\* Micro-electrodes and multi-electrode arrays (Utah-array) record local field potentials (LFP) and spike-activity. The outcome measure for spike activity is spike rate. For the local field potentials, the main outcome measure for visual research is the power in the gamma band. The main outcome measure for motor research is power increase in the beta and gamma band.
Neurophysiological study of different brain areas: fMRI	15 years	The outcome measure is blood oxygen level dependent (BOLD) signal changed in response to visual and/ or motor experiments.

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium