Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383689
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-10
Brief Title:
Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Placebo Optimization of the Presurgical Long-term Video-EEG Monitoring OPERA
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPERA
Brief Summary:
The notion of genuine placebo effects on epileptic seizure events ie 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
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 facilitateaccelerate the occurrence of epileptic seizures PCB-S thereby shortening the required time for video-EEG monitoring or 2 to lead to a more stableimproved 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 patientsStart 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
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 facilitateaccelerate the occurrence of epileptic seizures PCB-S thereby shortening the required time for video-EEG monitoring or 2 to lead to a more stableimproved 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 patientsStart 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None