Optimizing Placebo Effects in Pre-surgical Video-EEG Monitoring for Epilepsy
Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring (OPERA)
NA · University Hospital, Bonn · NCT06383689
This study is testing if different types of placebo pills can help improve the emotional well-being of people undergoing video-EEG monitoring for epilepsy, while also seeing if they affect the timing of seizures.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bonn (other) |
| Locations | 1 site (Bonn, North Rhine-Westphalia) |
| Trial ID | NCT06383689 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of placebo pills on patients undergoing long-term video-EEG monitoring for presurgical epilepsy diagnostics. Participants will be pseudo-randomized into three groups: one receiving a placebo pill intended to accelerate seizure occurrence, another receiving a placebo for emotional well-being, and a control group without any placebo. The study aims to determine if the placebo can influence subjective well-being while hypothesizing that it will not affect the timing of seizure events. The findings could provide insights into the role of placebo effects in epilepsy management.
Who should consider this trial
Good fit: Ideal candidates are individuals eligible for presurgical epilepsy diagnostics who are undergoing long-term video-EEG monitoring.
Not a fit: Patients who are not eligible for presurgical diagnostics or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of placebo effects in epilepsy, potentially improving patient care and emotional well-being during monitoring.
How similar studies have performed: While the concept of placebo effects is well-documented, this specific approach to studying its impact on seizure timing and emotional well-being is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bonn, North Rhine-Westphalia
- Department of Epileptology, University Hospital Bonn — Bonn, North Rhine-Westphalia, Germany (RECRUITING)
Study contacts
- Principal investigator: Rainer Surges, Prof. — Department of Epileptology, University Hospital Bonn, Germany
- Study coordinator: Rainer Surges, Prof.
- Email: rainer.surges@ukbonn.de
- Phone: +49 228 287-15727
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Symptomatic Epilepsy, epilepsy, emotional well-being, placebo, video-EEG long-term monitoring, presurgical epilepsy diagnostics