[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434318":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":41,"responsibleParty":62,"collaborators":64,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":35,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":98,"whyStopped":35,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Masaryk University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Predicted responders","EXPERIMENTAL","Patients indicated VNS therapy as their standard for clinical care and are concerned about the prediction of VNS efficacy based on pre-implantation EEG, (≥50% seizure reduction).",[13],"Other: Statistical model for the prediction of VNS efficacy",{"label":15,"type":16,"description":17,"interventionNames":18},"Predicted non-responders","ACTIVE_COMPARATOR","Patients indicated VNS therapy as their standard for clinical care and are concerned about the prediction of VNS efficacy based on pre-implantation EEG, (\\\u003C50% seizure reduction).",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"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",[15,9],[25],"the verification of the real-life validity of the statistic classifier for prediction of VNS response based on pre-implantation EEG",[27],{"name":28,"affiliation":29,"role":30},"Milan Brazdil, Prof.","University Hospital st. Anne´s Brno","PRINCIPAL_INVESTIGATOR",[32,37],{"name":28,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","+420 543 182 684",null,"milan.brazdil@fnusa.cz",{"name":38,"role":33,"phone":39,"phoneExt":35,"email":40},"Irena Doležalová, MD","+420 543 182 654","irena.dolezalova@fnusa.cz",[42],{"facility":43,"status":35,"city":44,"state":35,"zip":45,"country":46,"countryCode":35,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"University Hospital St. Anne´s Brno","Brno","654 91","Czechia",{"type":48,"coordinates":49},"Point",[50,51],16.60796,49.19522,{"lat":51,"lon":50},[54,56,59,60],{"name":28,"role":33,"phone":55,"phoneExt":35,"email":36},"+420543182654",{"name":57,"role":33,"phone":58,"phoneExt":35,"email":40},"Irena Doležalová, Assoc. Prof.","+420543183324",{"name":28,"role":30,"phone":35,"phoneExt":35,"email":35},{"name":57,"role":61,"phone":35,"phoneExt":35,"email":35},"SUB_INVESTIGATOR",{"type":63,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR",[65,67,69],{"name":66,"class":6},"St. Anne's University Hospital Brno, Czech Republic",{"name":68,"class":6},"University Hospital, Motol",{"name":70,"class":6},"Na Homolce Hospital","100434318","prediction-of-vagal-nerve-stimulation-efficacy-in-drug-resistant-epilepsy-100434318",false,"NCT04935567","PRediction of Vagal Nerve Stimulation EfficaCy In Drug-reSistant Epilepsy","PRediction of Vagal Nerve Stimulation EfficaCy In Drug-reSistant Epilepsy: Prospective Study for Pre-implantation Prediction","PRECISE","Inclusion Criteria:\n\n* Drug-resistant epilepsy indicated to VNS based on clinical decision.\n* 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).\n* Age ≥ 18 years\n* Availability to record 20 minutes of EEG with photic stimulation, hyperventilation, and eye-opening\u002Fclosing according to the pre-defined protocol.\n* Availability of seizure diaries at least three months before VNS implantation OR reliable information about seizure frequency at least three months before VNS implantation\n* The ability of a patient\u002Ffamily member\u002Fcaregiver to record seizures precisely into seizure diaries OR the ability of a patient\u002Ffamily member\u002Fcaregiver to report seizures precisely different ways.\n* In cases with very high seizure frequency (several seizures per day), it is acceptable to report only the days without any seizures.\n\nExclusion Criteria:\n\n* 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\u002Fshe can be included in the study.\n* The presence of psychogenic non-epileptic seizures which cannot be reliably distinguished from epileptic seizures by a patient\u002Ffamily member\u002Fcaregiver.\n* The presence of other condition which can resemble epileptic seizures which cannot be reliably distinguished from epileptic seizures by a patient\u002Ffamily member\u002Fcaregiver.\n* Metabolic condition or other diseases, in which the increase of seizure frequency is expectable.\n* The inability of a patient to take regular visits which are required for VNS parameters settings or the study\n* Life expectancy shorter than two years","ALL","18 Years","85 Years",{"count":83,"type":84},120,"ESTIMATED","INTERVENTIONAL",[87],"NA","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.",[90],"Drug Resistant Epilepsy",[92,93,94,95,96,97],"Drug-resistant epilepsy","Vagal nerve stimulation","Efficacy predictability","Responders","Non-responders","EEG","NOT_YET_RECRUITING","2021-06-22",{"date":101,"type":102},"2021-06-23","ACTUAL",{"date":104,"type":84},"2021-12-01",{"date":106,"type":84},"2026-12-31",{"name":5,"class":6},1]