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NCT Number: NCT05307146

Brain Activity in Epilepsy

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Leuven

Leuven, 3000, Belgium

Location status: Recruiting

Location contact

Anaïs Van Hoylandt

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

macro/micro electrode recording

Device

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

Primary outcomes

  1. Electrophysiological recordings: single neuron recordings

    Time frame: 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)

  2. Electrophysiological recordings: LFP

    Time frame: 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)

  3. fMRI recordings

    Time frame: 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 outcomes

  1. Neurophysiological study of different brain areas: power gamma band

    Time frame: 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.

  2. Neurophysiological study of different brain areas: spike activity

    Time frame: 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.

  3. Neurophysiological study of different brain areas: fMRI

    Time frame: 15 years

    The outcome measure is blood oxygen level dependent (BOLD) signal changed in response to visual and/ or motor experiments.

Study contacts

Contact information is provided by the study sponsor or research team.

Anaïs Van Hoylandt

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Study of Brain Activity in Candidates for Epilepsy Surgery

Important dates

Study start
2013
Primary completion
2035
Study completion
2035
First posted
Apr 1, 2022
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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