Prediction of Vagal Nerve Stimulation Efficacy in Drug-Resistant Epilepsy (PRECISE): Prospective Study for Pre-implantation Prediction/Study Design

0564514 - ÚPT 2023 RIV CH eng J - Článek v odborném periodiku
Doležalová, I. - Koriťáková, E. - Součková, L. - Chrastina, J. - Chládek, Jan - Štěpánová, R. - Brázdil, M.
Prediction of Vagal Nerve Stimulation Efficacy in Drug-Resistant Epilepsy (PRECISE): Prospective Study for Pre-implantation Prediction/Study Design.
Frontiers in Neurology. Roč. 13, 21 March (2022), č. článku 839163. ISSN 1664-2295. E-ISSN 1664-2295
Grant CEP: GA MZd(CZ) NV19-04-00343
Výzkumná infrastruktura: CZECRIN III - 90128
Institucionální podpora: RVO:68081731
Klíčová slova: drug-resistant epilepsy * vagal nerve stimulation * efficacy prediction * statistical model * study design
Obor OECD: Neurosciences (including psychophysiology
Impakt faktor: 3.4, rok: 2022
Způsob publikování: Open access
https://www.frontiersin.org/articles/10.3389/fneur.2022.839163/full

Background: Vagal nerve stimulation (VNS) can be indicated in patients with drug-resistant epilepsy, who are not eligible for resective epilepsy surgery. In VNS therapy, the responder rate (i.e., percentage of subjects experiencing ≥50% seizure reduction) is ~50%. At the moment, there is no widely-accepted possibility to predict VNS efficacy in a particular patient based on pre-implantation data, which can lead to unnecessary surgery and improper allocation of financial resources. The principal aim of PRediction of vagal nerve stimulation EfficaCy In drug-reSistant Epilepsy (PRECISE) study is to verify the predictability of VNS efficacy by analysis of pre-implantation routine electroencephalogram (EEG). Methods: PRECISE is designed as a prospective multicentric 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 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 therapeutic response. The primary endpoint will be the accuracy of the statistical model for prediction of response to VNS therapy in terms of responders and non-responders. The secondary endpoint will be the quantification of differences in EEG power spectra (Relative Mean Power, %) between real-life responders and real-life non-responders to VNS therapy in drug-resistant epilepsy and the sensitivity and specificity of the model. Discussion: PRECISE relies on the results of our previous work, through which we developed a statistical classifier for VNS response (responders vs. non-responders) based on differences in EEG power spectra dynamics (Pre-X-Stim).
Trvalý link: https://hdl.handle.net/11104/0336177