Brain Activity in Epilepsy

Epilepsy Clinical Trial

Official title:

Study of Brain Activity in Candidates for Epilepsy Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05307146
• Other study ID #: S53126
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2013
• Est. completion date: January 1, 2035

Study information

• Verified date: March 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Anaïs Van Hoylandt
• Email: anais.vanhoylandt[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2035
• Est. primary completion date: January 1, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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