Brain Activity in Epilepsy

Study of Brain Activity in Candidates for Epilepsy Surgery

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

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Device: macro/micro electrode recording

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anaïs Van Hoylandt; Email: anais.vanhoylandt@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Anaïs Van Hoylandt; Email: anais.vanhoylandt@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: micro/macro electrode	Device: macro/micro electrode recording; intracranial macro/micro-electrode placement at the cerebral cortex or in deeper brain areas with te use of macro/micro electrode recording. Macro/micro electrodes are placed at the cerebral cortex or in deeper brain areas in order to precisely identify the epileptogenic focus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrophysiological recordings: single neuron recordings	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)	15 years
Electrophysiological recordings: LFP	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)	15 years
fMRI recordings	* 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.	15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurophysiological study of different brain areas: power gamma band	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.	15 years
Neurophysiological study of different brain areas: spike activity	* 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.	15 years
Neurophysiological study of different brain areas: fMRI	The outcome measure is blood oxygen level dependent (BOLD) signal changed in response to visual and/ or motor experiments.	15 years

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2013
• Primary Completion (Anticipated): January 1, 2035
• Study Completion (Anticipated): January 1, 2035

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: March 22, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: S53126

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes