protocolSection identificationModule nctId: NCT06383689, orgStudyIdInfo id: Az. 297/23-EP, briefTitle: Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring, acronym: OPERA, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: University Hospital, Bonn, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Symptomatic Epilepsy, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: monocentric single-blinded randomized clinical study on the effectiveness of covered placebo on epileptic seizure occurrence and emotional well-being with 3 study conditions: "seizure pill" (PCB-S), "well-being pill" (PCB-W) and no pill (control), primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, maskingDescription: Like in psychological studies, only patients can participate in the study who consent to accept that complete study information can only be provided after the entire study was finished (with an option to withdraw consent at that point) as information on ingredients of the study pill (which is placebo) must be concealed for inherent reasons (study on effects of covered placebo)., whoMasked: PARTICIPANT, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Seizure placebo pill, interventions name: Well-being placebo pill, outcomesModule primaryOutcomes measure: Latency to first epileptic seizure, secondaryOutcomes measure: Occurrence of an epileptic seizure, secondaryOutcomes measure: Early occurrence of an epileptic seizure within the first 72 hours, secondaryOutcomes measure: Number of epileptic seizures during the video-EEG, secondaryOutcomes measure: Number of early occurring epileptic seizures, secondaryOutcomes measure: Daily average frequency of epileptic seizures, secondaryOutcomes measure: Very early first epileptic seizure, secondaryOutcomes measure: Early epileptic seizure, secondaryOutcomes measure: Epileptic seizure within the first three days, secondaryOutcomes measure: Emotional well-being, secondaryOutcomes measure: Dissociative non-epileptic seizures, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Epileptology, University Hospital Bonn, city: Bonn, state: NRW, zip: 53127, country: Germany, contacts name: Rainer Surges, Prof., role: CONTACT, phone: +49 228 287-15727, email: rainer.surges@ukbonn.de, contacts name: Christian Hoppe, PD Dr., role: CONTACT, phone: +49 228 287-16172, email: christian.hoppe@ukbonn.de, geoPoint lat: 50.73438, lon: 7.09549, hasResults: False