Brain Activity in Epilepsy
Study of Brain Activity in Candidates for Epilepsy Surgery
1 other identifier
interventional
60
1 country
1
Brief Summary
Prospective interventional study with implantation of micro-electrodes to study the brain networks in epilepsy at high spatiotemporal resolution.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 18, 2013
CompletedFirst Submitted
Initial submission to the registry
January 18, 2019
CompletedFirst Posted
Study publicly available on registry
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2035
April 1, 2022
March 1, 2022
21.1 years
January 18, 2019
March 22, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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)
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)
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.
15 years
Secondary Outcomes (3)
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 Arms (1)
micro/macro electrode
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Age ≥18 yo
- Epilepsy patients undergoing intracranial electrode placement.
- Able to understand the procedure involved and to consent.
You may not qualify if:
- Age \< 18 yo
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven
Leuven, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 18, 2019
First Posted
April 1, 2022
Study Start
December 18, 2013
Primary Completion (Estimated)
January 1, 2035
Study Completion (Estimated)
January 1, 2035
Last Updated
April 1, 2022
Record last verified: 2022-03