Brain Activity in Epilepsy
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
macro/micro electrode recording
Sponsored by
About this trial
This is an interventional basic science trial for Epilepsy
Eligibility Criteria
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
Sites / Locations
- UZ LeuvenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
micro/macro electrode
Arm Description
Outcomes
Primary Outcome Measures
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)
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)
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05307146
First Posted
January 18, 2019
Last Updated
March 22, 2022
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT05307146
Brief Title
Brain Activity in Epilepsy
Official Title
Study of Brain Activity in Candidates for Epilepsy Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2013 (Actual)
Primary Completion Date
January 1, 2035 (Anticipated)
Study Completion Date
January 1, 2035 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
micro/macro electrode
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
macro/micro electrode recording
Intervention Description
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 Outcome Measure Information:
Title
Electrophysiological recordings: single neuron recordings
Description
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)
Time Frame
15 years
Title
Electrophysiological recordings: LFP
Description
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)
Time Frame
15 years
Title
fMRI recordings
Description
* 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.
Time Frame
15 years
Secondary Outcome Measure Information:
Title
Neurophysiological study of different brain areas: power gamma band
Description
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.
Time Frame
15 years
Title
Neurophysiological study of different brain areas: spike activity
Description
* 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.
Time Frame
15 years
Title
Neurophysiological study of different brain areas: fMRI
Description
The outcome measure is blood oxygen level dependent (BOLD) signal changed in response to visual and/ or motor experiments.
Time Frame
15 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anaïs Van Hoylandt
Email
anais.vanhoylandt@uzleuven.be
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anaïs Van Hoylandt
Email
anais.vanhoylandt@uzleuven.be
12. IPD Sharing Statement
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Brain Activity in Epilepsy
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