Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring (OPERA)
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• eligibility for presurgical epilepsy diagnostics
Locations
Other Locations
Germany
Department of Epileptology, University Hospital Bonn
RECRUITING
Bonn
Contact Information
Primary
Rainer Surges, Prof.
rainer.surges@ukbonn.de
+49 228 287-15727
Backup
Christian Hoppe, PD Dr.
christian.hoppe@ukbonn.de
+49 228 287-16172
Time Frame
Start Date: 2024-05-13
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 90
Treatments
Experimental: Seizure placebo pill (PCB-S)
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)
Experimental: 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
No_intervention: No pill (control)
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
Sponsors
Leads: University Hospital, Bonn