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Clinical Trials/NCT05307146
NCT05307146
Recruiting
Not Applicable

Study of Brain Activity in Candidates for Epilepsy Surgery

Universitaire Ziekenhuizen KU Leuven1 site in 1 country60 target enrollmentDecember 18, 2013
ConditionsEpilepsy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy
Sponsor
Universitaire Ziekenhuizen KU Leuven
Enrollment
60
Locations
1
Primary Endpoint
Electrophysiological recordings: single neuron recordings
Status
Recruiting
Last Updated
4 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 18, 2013
End Date
January 1, 2035
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tom Theys

Principal Investigator

Universitaire Ziekenhuizen KU Leuven

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Neurophysiological study of different brain areas: power gamma band(15 years)
  • Neurophysiological study of different brain areas: spike activity(15 years)
  • Neurophysiological study of different brain areas: fMRI(15 years)

Study Sites (1)

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