EpilepsyNCT05307146
Brain Activity in Epilepsy
A study testing macro/micro electrode recording in people with Epilepsy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Prospective interventional study with implantation of micro-electrodes to study the brain networks in epilepsy at high spatiotemporal resolution. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- macro/micro electrode recording
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Dec 2013to 1 Jan 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 yo
- Epilepsy patients undergoing intracranial electrode placement.
- Able to understand the procedure involved and to consent.
Who cannot join
- Age < 18 yo
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anaïs Van Hoylandt contact
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Anaïs Van Hoylandt, anais.vanhoylandt@uzleuven.be
About this study
Official title: 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.
Read the 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
- Conditions
- Epilepsy
- Being tested
- macro/micro electrode recording
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
macro/micro electrode recordingDevice
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
| Study group | Role | What they receive |
|---|---|---|
| micro/macro electrode | Experimental | Not described Receives: Device: macro/micro electrode recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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.
Measured: 15 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start18 Dec 2013
- Primary completion1 Jan 2035 (estimated)
- Study completion1 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Theys, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05307146
- Sponsor's protocol ID
- S53126
- Status last verified
- Mar 2022
- First submitted
- 18 Jan 2019
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Brain Activity in Candidates for Epilepsy Surgery
- ClinicalTrials.gov ID
- NCT05307146
- Acronym / sponsor ID
- S53126
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 18 Dec 2013 (actual)
- Primary completion
- 1 Jan 2035 (estimated)
- Study completion
- 1 Jan 2035 (estimated)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| micro/macro electrode | Experimental | Device: macro/micro electrode recording |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 yo
- Epilepsy patients undergoing intracranial electrode placement.
- Able to understand the procedure involved and to consent.
Key exclusion criteria (2 listed)
- Age < 18 yo
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| macro/micro electrode recordingintracranial 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 | Device | micro/macro electrode |
Primary outcome
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)
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)
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.
3 secondary outcomes
Neurophysiological study of different brain areas: power gamma band
Time frame: 15 years
Neurophysiological study of different brain areas: spike activity
Time frame: 15 years
Neurophysiological study of different brain areas: fMRI
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anaïs Van Hoylandt contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing macro/micro electrode recording in people with Epilepsy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anaïs Van Hoylandt (anais.vanhoylandt@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrophysiological recordings: single neuron recordings (time frame: 15 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.