Testing Placebo Pills During Long-Term Video-EEG Monitoring for Epilepsy
Tests placebo pills in adults with epilepsy during presurgical seizure monitoring.
Plain-language title generated from the registry record
Registry title: Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring
Key facts
- Where
- Bonn, GermanySee the site
Where in Germany
- Department of Epileptology, University Hospital BonnBonn, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Bonn
- Trial code
- NCT06383689
- Record updated
- 10 June 2024
- Original description
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.Read full original descriptionShow less
Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring (OPERA)
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.
Inclusion: eligibility for presurgical epilepsy diagnostics.
Exclusion: inclusion criterion implies all exclusion criteria for this procedure; legal guardian; lack of consent or lack of capability to provide informed consent.