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

NCT06383689 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-06-10

No results posted yet for this study

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.

Conditions

  • Symptomatic Epilepsy

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

Sponsors & Collaborators

  • University Hospital, Bonn

    lead OTHER

Principal Investigators

  • Rainer Surges, Prof. · Department of Epileptology, University Hospital Bonn, Germany

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-13
Primary Completion
2026-04-30
Completion
2026-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06383689 on ClinicalTrials.gov