Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Seizure placebo pill, Well-being placebo pill.
- Who it may be relevant to
- Registry conditions: Symptomatic Epilepsy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring (OPERA)
Overview
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.
Detailed description
Patients undergoing long-term video-EEG monitoring for the purpose of pre-operative epilepsy diagnostics will be invited to participate in the study. Patients will be pseudo-randomized into three study conditions (in blocks of six). The study participants will take a placebo pill designated either as a "seizure pill" (Condition PCB-S) or a "comfort pill" (PCB-W) in addition to their regular medication in the morning and evening, or not receive any additional placebo medication (No-PCB).
Both the "seizure pill" and the "comfort pill" are commercially available, ingredient-free placebo pills (P-pills blue Lichtenstein, produced by Winthrop Pharmaceuticals). No further details about the composition of the pill will be provided; information about the ingredients of the respective pill will be provided after the end of the entire study. Depending on randomization, study participants will be informed that this pill is expected to (1) either facilitate/accelerate the occurrence of epileptic seizures (PCB-S) (thereby shortening the required time for video-EEG monitoring), or (2) to lead to a more stable/improved emotional well-being during the stay in the V-EEG (PCB-W) or (3) will not receive a pill but are asked to fill-in questionnaires and diaries like the other patients.Start of the V-EEG will be documented as the starting point for latency measurement for the occurrence of a first epileptic seizure. The patients will be pseudo-randomized into the three study conditions: Out of every 6 patients, 2 will be assigned to each of the three study conditions. Patients in both active study conditions will receive the first pill at the start of the V-EEG. After that, study participants will receive the respective "pill" morning and evening in addition to their other medications, however, visibly separated from them and clearly marked as study medication. All participants, including controls, will keep a seizure diary during the V-EEG. In addition, they will fill-in a newly constructed ad-hoc questionnaire at the beginning and after the V-EEG. Finally, all patients will be asked twice daily (around 9 AM and around 6 PM) about their overall emotional well-being using a visual analogue scale (VAS; 0 very bad ... 100 extremely good). The highly standardized clinical procedures of presurgical evaluation are in no way affected by the study. In particular, anti-seizure medications for all patients will be tapered off following exactly the same schedule without any influence from the study; the medication will be precisely documented.
Interventions
- Other 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 - Other 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
Primary outcome measures
- Latency to first epileptic seizure [Time frame: immediately after video-EEG monitoring]
Secondary outcome measures (10)
- Occurrence of an epileptic seizure [Time frame: immediately after video-EEG monitoring]
- Early occurrence of an epileptic seizure within the first 72 hours [Time frame: immediately after video-EEG monitoring]
- Number of epileptic seizures during the video-EEG [Time frame: immediately after video-EEG monitoring]
- Number of early occurring epileptic seizures [Time frame: 72 hours after video-EEG monitoring]
- Daily average frequency of epileptic seizures [Time frame: immediately after video-EEG monitoring]
- Very early first epileptic seizure [Time frame: after 1st day after video-EEG monitoring]
- Early epileptic seizure [Time frame: after 2nd day after video-EEG monitoring]
- Epileptic seizure within the first three days [Time frame: after 3rd day after video-EEG monitoring]
- Emotional well-being [Time frame: immediately after video-EEG monitoring]
- Dissociative non-epileptic seizures [Time frame: immediately after video-EEG monitoring]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Germany · 1 center
- Department of Epileptology, University Hospital Bonn — Bonn
Identifiers
NCT: NCT06383689 · Az. 297/23-EP