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PRediction of Vagal Nerve Stimulation EfficaCy In Drug-reSistant Epilepsy

NCT04935567 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-06-23

No results posted yet for this study

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.

Conditions

  • Drug Resistant Epilepsy

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

Sponsors & Collaborators

  • St. Anne's University Hospital Brno, Czech Republic

    collaborator OTHER

  • University Hospital, Motol

    collaborator OTHER

  • Na Homolce Hospital

    collaborator OTHER

  • Masaryk University

    lead OTHER

Principal Investigators

  • Milan Brazdil, Prof. · University Hospital st. Anne´s Brno

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2024-12-31
Completion
2026-12-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04935567 on ClinicalTrials.gov