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Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring
Sponsor: University Hospital, Bonn
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.
Official title: Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring (OPERA)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-05-13
Completion Date
2026-12-31
Last Updated
2024-06-10
Healthy Volunteers
No
Conditions
Interventions
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
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
Locations (1)
Department of Epileptology, University Hospital Bonn
Bonn, North Rhine-Westphalia, Germany