Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring (OPERA)

Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring (OPERA)

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.

Study Overview

• Status: Recruiting
• Conditions: Symptomatic Epilepsy
• Intervention / Treatment: Other: Seizure placebo pill; Other: Well-being placebo pill

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.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rainer Surges, Prof.; Phone Number: +49 228 287-15727; Email: rainer.surges@ukbonn.de
• Study Contact Backup: Name: Christian Hoppe, PD Dr.; Phone Number: +49 228 287-16172; Email: christian.hoppe@ukbonn.de

Study Locations

• Germany
  • NRW
    • Bonn, NRW, Germany, 53127
      • Recruiting
      • Department of Epileptology, University Hospital Bonn
      • Contact: Rainer Surges, Prof.; Phone Number: +49 228 287-15727; Email: rainer.surges@ukbonn.de
      • Contact: Christian Hoppe, PD Dr.; Phone Number: +49 228 287-16172; Email: christian.hoppe@ukbonn.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seizure placebo pill (PCB-S); 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; 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 Names: PCB-S
Experimental: Well-being placebo pill (PCB-W); 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; 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; Other Names: PCB-W
No Intervention: No pill (control); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of an epileptic seizure	Occurrence of an epileptic seizure during the video-EEG (yes/no)	immediately after video-EEG monitoring
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)	immediately after video-EEG monitoring
Number of epileptic seizures during the video-EEG	Total number of epileptic seizures which occurred during the video-EEG	immediately after video-EEG monitoring
Number of early occurring epileptic seizures	Total number of epileptic seizures recorded during the first 72 hours of video-EEG	72 hours after video-EEG monitoring
Daily average frequency of epileptic seizures	Average daily frequency of epileptic seizures during the entire video-EEG (calculated)	immediately after video-EEG monitoring
Very early first epileptic seizure	First epileptic seizure on the first day of video-EEG (yes/no)	after 1st day after video-EEG monitoring
Early epileptic seizure	First epileptic seizure on the first or second day of video-EEG (yes/no)	after 2nd day after video-EEG monitoring
Epileptic seizure within the first three days	First epileptic seizure within the first three days of video-EEG (yes/no).	after 3rd day after video-EEG monitoring
Emotional well-being	Visual analogue scales (diary), 2x daily queries (9 am, 6 pm): mean and standard deviation (stability), during the video-EEG	immediately after video-EEG monitoring
Dissociative non-epileptic seizures	occurrence of dissociative non-epileptic seizures during video-EEG (yes/no)	immediately after video-EEG monitoring

Collaborators and Investigators

• Sponsor: University Hospital, Bonn
• Investigators: Principal Investigator: Rainer Surges, Prof., Department of Epileptology, University Hospital Bonn, Germany

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 10, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 10, 2024
• Last Update Submitted That Met QC Criteria: June 7, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: epilepsy; placebo; emotional well-being; video-EEG long-term monitoring; presurgical epilepsy diagnostics
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: Az. 297/23-EP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No