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NCT04935567: PRECISE
PRediction of Vagal Nerve Stimulation EfficaCy In Drug-reSistant Epilepsy
NA trial testing Statistical model for the prediction of VNS efficacy in Drug Resistant Epilepsy in 120 participants. Not yet recruiting.
31 December 2024
Quick facts
| Lead sponsor | Masaryk University |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 120 |
| Start date | 1 December 2021 |
| Primary completion | 31 December 2024 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across Czechia |
Drugs / interventions tested
- Statistical model for the prediction of VNS efficacy
Conditions studied
- Drug Resistant Epilepsy — all drugs for Drug Resistant Epilepsy →
Sponsor
Masaryk University
Who can join
Adults 18 to 85, any sex, with Drug Resistant Epilepsy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Prediction of Vagal Nerve Stimulation Efficacy in Drug-Resistant Epilepsy (PRECISE): Prospective Study for Pre-implantation Prediction/Study Design.
Dolezalova I, Koritakova E, Souckova L, Chrastina J, et al · · 2022 · cited 7× · PMID 35386419 · DOI 10.3389/fneur.2022.839163
Verify or expand the search:
- PubMed search for NCT04935567
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04935567 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Masaryk University
- Last refreshed: 23 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04935567.
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