Placebo optimization of the presurgical video-EEG long-term monitoring

Placebo optimization of the presurgical video-EEG long-term monitoring - OPERA

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00034056

Enrollment

Registered

2024-04-10

Start date

2024-05-13

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G40.1 G40.2

Interventions

Group 1: daily intake of a covered placebo (1-0-1) associated with the information of an expected possible seizure facilitating effect (i.e. accelerated incidence of an epileptic seizures and, therefo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: medical indication for mandatory seizure recording via video-EEG long-term monitoring in the context of presurgical epilepsy diagnosis (implies all exclusion criteria for V-EEG)

Exclusion criteria

Exclusion criteria: - lack of informed consent or respective capability to provide consent - patient has a legal guardian - known allergy for ingredient of placebo pill Of note, comorbid dissociative non-epileptic seizures are no exclusion criterion.

Design outcomes

Primary

Measure	Time frame
temporal latency from beginning the V-EEG monitoring to the occurrence of the first epileptic seizure	—

Secondary

Measure	Time frame
Sure, here's the translation into English: Occurrence of an epileptic seizure during the V-EEG (yes/no) Occurrence of an epileptic seizure within the first 72 hours (yes/no) Number of epileptic seizures occurred during the V-EEG Number of epileptic seizures recorded during the first 72 hours Average daily frequency of epileptic seizures during the entire V-EEG (hourly extrapolated to the day) Day of the first occurrence of an epileptic seizure (categorical, cumulative): - First epileptic seizure on the first day (yes/no) - First epileptic seizure on the first or second day (yes/no) - First epileptic seizure within the first three days (yes/no). Visual analogue scale, 2x daily queries (9 AM, 6 PM): Mean and standard deviation (stability) during the V-EEG Additional items on well-being (Before/After questionnaire)	—

Measure

Time frame

Sure, here's the translation into English: Occurrence of an epileptic seizure during the V-EEG (yes/no) Occurrence of an epileptic seizure within the first 72 hours (yes/no) Number of epileptic seizures occurred during the V-EEG Number of epileptic seizures recorded during the first 72 hours Average daily frequency of epileptic seizures during the entire V-EEG (hourly extrapolated to the day) Day of the first occurrence of an epileptic seizure (categorical, cumulative): - First epileptic seizure on the first day (yes/no) - First epileptic seizure on the first or second day (yes/no) - First epileptic seizure within the first three days (yes/no). Visual analogue scale, 2x daily queries (9 AM, 6 PM): Mean and standard deviation (stability) during the V-EEG Additional items on well-being (Before/After questionnaire)

—

Countries

Germany

Contacts

Public ContactRainer Surges

Universitätsklinikum Bonn, Klinik und Poliklinik für Epileptologie

rainer.surges@ukbonn.de+49 228 287-15727

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026