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NOT YET RECRUITING
NCT04935567
NA

PRediction of Vagal Nerve Stimulation EfficaCy In Drug-reSistant Epilepsy

Sponsor: Masaryk University

View on ClinicalTrials.gov

Summary

Vagal nerve stimulation (VNS) can be indicated in patients with drug-resistant epilepsy who are not eligible for resective epilepsy surgery with responders rates about 50% (≥50% seizure reduction). At the moment, there is not a widely-accepted possibility to predict VNS efficacy in a given patient based on pre-implantation data, which can lead to unnecessary surgery and improper allocation of financial resources. The principal aim of PRECISE (PRediction of vagal nerve stimulation EfficaCcy In drug-reSistant Epilepsy) study is to verify the predictability of VNS efficacy by analysis of pre-implantation routine EEG. The PRECISE relies on the results of our previous work, which developed a statistical classifier for VNS response (responders vs. non-responders) based on differences in EEG power spectra dynamics (Pre-X-Stim). PRECISE is designed as a prospective multicentre study in which patients indicated to VNS therapy will be recruited. Patients will be classified as predicted responders vs. predicted non-responders using pre-implantation EEG analyses. After the first and the second year of the study, the real-life outcome (responder vs. non-responder) will be determined. The real-life outcome and predicted outcome will be compared in terms of accuracy, specificity, and sensitivity. In the meantime, the patients will be managed according to the best clinical practice to obtain the best therapeutical response.

Official title: PRediction of Vagal Nerve Stimulation EfficaCy In Drug-reSistant Epilepsy: Prospective Study for Pre-implantation Prediction

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2021-12-01

Completion Date

2026-12-31

Last Updated

2021-06-23

Healthy Volunteers

No

Interventions

OTHER

Statistical model for the prediction of VNS efficacy

statistical model for the prediction of VNS efficacy based on a mathematical and statistical analysis of scalp EEG data

Locations (1)

University Hospital St. Anne´s Brno

Brno, Czechia