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

NCT06383689 | Recruiting

• 1 other identifier: Az. 297/23-EP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

epilepsy; emotional well-being; placebo; video-EEG long-term monitoring; presurgical epilepsy diagnostics

Outcome Measures

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

  immediately after video-EEG monitoring

Secondary Outcomes (10)

• Occurrence of an epileptic seizure

  immediately after video-EEG monitoring

• Early occurrence of an epileptic seizure within the first 72 hours

  immediately after video-EEG monitoring

• Number of epileptic seizures during the video-EEG

  immediately after video-EEG monitoring

• Number of early occurring epileptic seizures

  72 hours after video-EEG monitoring

• Daily average frequency of epileptic seizures

  immediately after video-EEG monitoring

Study Arms (3)

Seizure placebo pill (PCB-S)

EXPERIMENTAL

Patients assigned to this condition receive a covered placebo pill (1-0-1) on a daily basis with the indication of possible acceleration of the occurrence of an epileptic seizure (which then allows to conclude V-EEG monitoring faster)

Other: Seizure placebo pill

Well-being placebo pill (PCB-W)

EXPERIMENTAL

Patients assigned to this condition receive a covered placebo pill (1-0-1) on a daily basis with the indication of possible improvement of emotional well-being during the demanding V-EEG monitoring procedure

Other: Well-being placebo pill

No pill (control)

NO INTERVENTION

Patients assigned to this condition receive no study pill but are asked to fill-in all questionnaires and diaries like patients in the two active arms

Interventions

Seizure placebo pill OTHER

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

Also known as: PCB-S

Seizure placebo pill (PCB-S)

Well-being placebo pill OTHER

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

Also known as: PCB-W

Well-being placebo pill (PCB-W)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• eligibility for presurgical epilepsy diagnostics

You may not qualify if:

• legal guardian
• lack of consent or lack of capability to provide informed consent

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

Department of Epileptology, University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Rainer Surges, Prof.

  Department of Epileptology, University Hospital Bonn, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rainer Surges, Prof.

CONTACT

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

Christian Hoppe, PD Dr.

CONTACT

+49 228 287-16172; christian.hoppe@ukbonn.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Like in psychological studies, only patients can participate in the study who consent to accept that complete study information can only be provided after the entire study was finished (with an option to withdraw consent at that point) as information on ingredients of the study pill (which is placebo) must be concealed for inherent reasons (study on effects of covered placebo).
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher (Clinical Neuropsychologist)

Model Details: monocentric single-blinded randomized clinical study on the effectiveness of covered placebo on epileptic seizure occurrence and emotional well-being with 3 study conditions: "seizure pill" (PCB-S), "well-being pill" (PCB-W) and no pill (control)

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 25, 2024
• Study Start: May 13, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)