Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring
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 epilep
| Condition(s) | Symptomatic Epilepsy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: * eligibility for presurgical epilepsy diagnostics Exclusion Criteria: * inclusion criterion implies all exclusion criteria for this procedure * legal guardian * lack of consent or lack of capability to provide informed consent |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University Hospital, Bonn |
| Locations | Bonn, North Rhine-Westphalia, Germany |
| Start date | 2024-05-13 |
| NCT ID | NCT06383689 |
| Official listing | https://clinicaltrials.gov/study/NCT06383689 |