[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545575":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":42,"locations":51,"responsibleParty":69,"collaborators":23,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":23,"enrollmentInfo":82,"targetDuration":23,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":54,"whyStopped":23,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University Hospital, Bonn","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Seizure placebo pill (PCB-S)","EXPERIMENTAL","Patients assigned to this condition receive a covered placebo pill (1-0-1) on a daily basis with the indication of possible acceleration of the occurrence of an epileptic seizure (which then allows to conclude V-EEG monitoring faster)",[13],"Other: Seizure placebo pill",{"label":15,"type":10,"description":16,"interventionNames":17},"Well-being placebo pill (PCB-W)","Patients assigned to this condition receive a covered placebo pill (1-0-1) on a daily basis with the indication of possible improvement of emotional well-being during the demanding V-EEG monitoring procedure",[18],"Other: Well-being placebo pill",{"label":20,"type":21,"description":22,"interventionNames":23},"No pill (control)","NO_INTERVENTION","Patients assigned to this condition receive no study pill but are asked to fill-in all questionnaires and diaries like patients in the two active arms",null,[25,31],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Seizure placebo pill","patients in this study arm receive a covered placebo pill on a daily basis (1-0-1) with the indication of possible acceleration of seizure occurrence during presurgical video-EEG",[9],[30],"PCB-S",{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Well-being placebo pill","patients in this study arm receive a covered placebo pill on a daily basis (1-0-1) with the indication of possible improvement of emotional well-being during video-EEG",[15],[36],"PCB-W",[38],{"name":39,"affiliation":40,"role":41},"Rainer Surges, Prof.","Department of Epileptology, University Hospital Bonn, Germany","PRINCIPAL_INVESTIGATOR",[43,47],{"name":39,"role":44,"phone":45,"phoneExt":23,"email":46},"CONTACT","+49 228 287-15727","rainer.surges@ukbonn.de",{"name":48,"role":44,"phone":49,"phoneExt":23,"email":50},"Christian Hoppe, PD Dr.","+49 228 287-16172","christian.hoppe@ukbonn.de",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Department of Epileptology, University Hospital Bonn","RECRUITING","Bonn","North Rhine-Westphalia","53127","Germany","DE",{"type":61,"coordinates":62},"Point",[63,64],7.09549,50.73438,{"lat":64,"lon":63},[67,68],{"name":39,"role":44,"phone":45,"phoneExt":23,"email":46},{"name":48,"role":44,"phone":49,"phoneExt":23,"email":50},{"type":41,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Christian Hoppe","Senior Researcher (Clinical Neuropsychologist)","100545575","placebo-optimization-of-the-presurgical-long-term-video-eeg-monitoring-100545575",false,"NCT06383689","Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring","Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring (OPERA)","OPERA","Inclusion Criteria:\n\n* eligibility for presurgical epilepsy diagnostics\n\nExclusion Criteria:\n\n* inclusion criterion implies all exclusion criteria for this procedure\n* legal guardian\n* lack of consent or lack of capability to provide informed consent","ALL","18 Years",{"count":83,"type":84},90,"ESTIMATED","INTERVENTIONAL",[87],"NA","The notion of genuine placebo effects on epileptic seizure events (i.e., effects beyond methodological study artifacts) is incompatible with the standard model of epilepsy seizure genesis. In this single-blind controlled study, the effectiveness of a covered placebo on (1) the timing of the occurrence of a first epileptic seizure (\"seizure pill\") versus (2) the subjective well-being (\"comfort pill\") during pre-surgical video-EEG monitoring will be examined. It is hypothesized that a placebo effect on subjective well-being can be demonstrated, but that epileptic seizure events are not influenced by placebo.",[90],"Symptomatic Epilepsy",[92,93,94,95,96],"epilepsy","emotional well-being","placebo","video-EEG long-term monitoring","presurgical epilepsy diagnostics","2024-06-07",{"date":99,"type":100},"2024-06-10","ACTUAL",{"date":102,"type":100},"2024-05-13",{"date":104,"type":84},"2026-12-31",{"name":5,"class":6},1]