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Recruiting NCT05307146

Brain Activity in Epilepsy

No phase Interventional Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: macro/micro electrode recording.
Who it may be relevant to
Registry conditions: Epilepsy. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Study of Brain Activity in Candidates for Epilepsy Surgery

Overview

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

Interventions

  • 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

Primary outcome measures

  • Electrophysiological recordings: single neuron recordings [Time frame: 15 years]
  • Electrophysiological recordings: LFP [Time frame: 15 years]
  • fMRI recordings [Time frame: 15 years]
Secondary outcome measures (3)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

Belgium · 1 center
  • UZ Leuven — Leuven

Identifiers

NCT: NCT05307146 · S53126

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗