NCT06383689Recruiting
Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring
Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring (OPERA)
Source: ClinicalTrials.gov · Last updated 10 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 10 Apr 2024
- Start date
- 13 May 2024
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- University Hospital, Bonn
- Diseases
- Epilepsy
- NCT number
- NCT06383689
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 13 May 2024 to the primary completion date, 30 Apr 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- inclusion criterion implies all exclusion criteria for this procedure
- legal guardian
- lack of consent or lack of capability to provide informed consent
Who the study is looking for
- eligibility for presurgical epilepsy diagnostics
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Epileptology, University Hospital Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.