Health TrialsbyHealthPanel

Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring

ConditionSymptomatic Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bonn

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

eligibility for presurgical epilepsy diagnostics

Disqualifiers

inclusion criterion implies all exclusion criteria for this procedure

legal guardian

lack of consent or lack of capability to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Seizure placebo pill

    Other intervention

    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

  • Well-being placebo pill

    Other intervention

    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

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Seizure placebo pill (PCB-S)Experimental treatment 1 intervention
Group B: Well-being placebo pill (PCB-W)Experimental treatment 1 intervention
Group C: No pill (control)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Latency to first epileptic seizure

temporal latency from beginning of the video-EEG monitoring to the occurrence of the first epileptic seizure

Time frame
immediately after video-EEG monitoring

Secondary outcomes

1

Occurrence of an epileptic seizure

Occurrence of an epileptic seizure during the video-EEG (yes/no)

Time frame
immediately after video-EEG monitoring
2

Early occurrence of an epileptic seizure within the first 72 hours

Early occurrence of an epileptic seizure within the first 72 hours of video-EEG monitoring (yes/no)

Time frame
immediately after video-EEG monitoring
3

Number of epileptic seizures during the video-EEG

Total number of epileptic seizures which occurred during the video-EEG

Time frame
immediately after video-EEG monitoring
4

Number of early occurring epileptic seizures

Total number of epileptic seizures recorded during the first 72 hours of video-EEG

Time frame
72 hours after video-EEG monitoring

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Bonn

Lead sponsor

Source ClinicalTrials.gov
Apply now