Predicting Vagal Nerve Stimulation Response in Drug-Resistant Epilepsy
Tests whether an EEG-based model can predict who responds to vagus nerve stimulation.
Plain-language title generated from the registry record
Registry title: PRediction of Vagal Nerve Stimulation EfficaCy In Drug-reSistant Epilepsy
Key facts
- Where
- Brno, CzechiaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with epilepsy that does not respond to medicines, for whom doctors have decided on vagal nerve stimulation (VNS).
- Age
- 18 to 85 years
- Sex
- All sexes
- Disease stage
- Drug-resistant epilepsy: seizures were not controlled by two well-chosen and well-used antiepileptic drug schedules. Doctors have decided on VNS.
- Earlier treatment
- At least two antiepileptic drug schedules that failed to stop seizures.
Main reasons for not taking part
- Resection brain surgery is planned or indicated (unless the patient clearly refuses it)
- Non-epileptic seizures or look-alike conditions that cannot be told apart from epileptic seizures
- Another condition in which more seizures are expected
- Cannot attend the regular visits needed for VNS settings or the study
- Life expectancy shorter than two years
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT04935567, who can take part
Where in Czechia
- University Hospital St. Anne´s BrnoBrno, CzechiaContact: Milan Brazdil, Prof.No longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Masaryk University
- Trial code
- NCT04935567
- Record updated
- 23 June 2021
- Original 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.Read full original descriptionShow less
PRediction of Vagal Nerve Stimulation EfficaCy In Drug-reSistant Epilepsy: Prospective Study for Pre-implantation Prediction
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.
Inclusion: Drug-resistant epilepsy indicated to VNS based on clinical decision; Drug-resistant epilepsy is defined as a failure of adequate trials of two tolerated, appropriately chosen, and used antiepileptic drug schedules (whether as monotherapy or in combination) to achieve sustained seizure freedom (Kwan et al., 2010); Age ≥ 18 years; Availability to record 20 minutes of EEG with photic stimulation, hyperventilation, and eye-opening/closing according to the pre-defined protocol; Availability of seizure diaries at least three months before VNS implantation OR reliable information about seizure frequency at least three months before VNS implantation; The ability of a patient/family member/caregiver to record seizures precisely into seizure diaries OR the ability of a patient/family member/caregiver to report seizures precisely different ways; In cases with very high seizure frequency (several seizures per day), it is acceptable to report only the days without any seizures.
Exclusion: The indication and planning of resection brain surgery as a treatment option for drug-resistant epilepsy. If a patient clearly demonstrates his refusal of resection surgery, he/she can be included in the study; The presence of psychogenic non-epileptic seizures which cannot be reliably distinguished from epileptic seizures by a patient/family member/caregiver; The presence of other condition which can resemble epileptic seizures which cannot be reliably distinguished from epileptic seizures by a patient/family member/caregiver; Metabolic condition or other diseases, in which the increase of seizure frequency is expectable; The inability of a patient to take regular visits which are required for VNS parameters settings or the study; Life expectancy shorter than two years.