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Ιn the present study (BIOEPI), the following three hypotheses will be investigated:
The overarching objective of this study is to develop a combined TMS-EEG/EMG protocol so as to explore the effects of AEDs on cortical excitability and obtain novel electrophysiological biomarkers which could help predict the response of epileptic patients to AEDs, in line with the principles of personalized medicine. In order to achieve the overarching objective, we will perform a Diagnostic Clinical Performance Study, (FDA 2013) with the following specific objectives.
Primary Objective 1: To investigate whether TMS-EEG/EMG biomarkers can predict the response of patients with focal epilepsy to AEDs (Lacosamide & Brivaracetam).
Secondary Objective 1: Development, testing and validation of novel TMS-EEG/EMG stimulation and multi-level data analysis protocols, incorporating advanced methods of signal analysis, connectivity, complexity, and propagation across the cortical mantle.
Secondary Objective 2: Investigating the sensitivity of TMS-EEG/EMG biomarkers for detecting changes in brain physiology in healthy subjects and patients with focal epilepsy.Secondary Objective 3: Investigating whether TMS-EEG / EMG biomarkers may predict cognitive deficits in patients with focal epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Other | Each healthy volunteer during Part I of the study will receive every 2 weeks a single per os dose of Lacosamide (200 mg), Brivaracetam (50 mg) or placebo. All healthy volunteers will perform tests using the new software that combines Transcranial Magnetic Stimulation Combined With EEG/EMG, |
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| Patients with focal epilepsy | Other | Patients during Part II, will receive the treatment according to the treating physician's discretion, regardless of the protocol, either with Lacosamide, 300 mg p.o. or Brivaracetam, 100 mg p.o. All patients will perform tests using the new software that combines Transcranial Magnetic Stimulation Combined With EEG/EMG, |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Software EstimLT | Device | Healthy volunteers will receive a single per os dose of Lacosamide (200 mg), Brivaracetam (50 mg) or placebo and then the software will be tested |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of TMS Combined With EEG/EMG for predicting response to AEDs | The Primary Outcome Measure is the diagnostic accuracy (calculated as the number of true positives + true negatives)/(number of true positives + true negatives + false positives + false negatives) of the index test for predicting response to AEDs (defined as reduction of seizure frequency by 50% or more during the maintenance period in comparison to baseline). The primary efficacy endpoint will be assessed in the combined groups of responders (LAC+BRV) and non-responders (LAC+BRV) because the starting hypothesis is that response to AEDs will be associated with alterations in TMS-EEG/EMG biomarkers. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| PPV, NPV, LR+ & LR- of TMS Combined With EEG/EMG for predicting response to AEDs | Positive Predictive Value (PPV), Negative Predictive Value (NPV), positive likelihood ratio (LR+) & negative likelihood ratio (LR-) of TMS Combined With EEG/EMG for predicting response to AEDs (defined as reduction of seizure frequency by 50% or more). | Through study completion, an average of 2 years |
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Inclusion Criteria:
General criteria:
Specific criteria:
The specific criteria per group of study participants are as follows:
Patient Group:
Healthy control group:
Adult, healthy volunteers, 18-65 years of age
Exclusion Criteria:
The specific criteria per group of study participants are as follows:
Patient Group:
Healthy control group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vasilios Kimiskidis, Professor | Contact | +30-2310-994667 | kimiskid@auth.gr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof. Vasilios Kimiskidis | Recruiting | Thessaloniki | Thessaloniki | 546 36 | Greece |
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| ID | Term |
|---|---|
| D004828 | Epilepsies, Partial |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The study has 2 parts; part I that includes healthy volunteers and part II that includes patients with focal epilepsy. Each healthy volunteer will participate in three sessions every 2 weeks and will receive a single per os dose of Lacosamide (200 mg), Brivaracetam (50 mg) or placebo. Patients in part II will receive either Lacosamide, 300 mg p.o. or Brivaracetam, 100 mg p.o. All participants will perform a test using the tested software that combines a Transcranial Magnetic Stimulation with EEG/EMG
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The evaluator of the outcomes will be blinded
| Accuracy, PPV, NPV, LR+ & LR- of TMS Combined With EEG/EMG for other measures of response to AEDs | Accuracy, PPV, NPV, positive likelihood ratio (LR+) & negative likelihood ratio (LR-) of TMS Combined With EEG/EMG for other measures of response to AEDs (i.e. percent seizure reduction, seizure freedom, time to n th (n=1,5th,10th) seizure). | Through study completion, an average of 2 years |
| Accuracy of TMS Combined With EEG/EMG for predicting AED-induced side-effects | Accuracy of TMS Combined With EEG/EMG for predicting AED-induced cognitive side-effects and other study-emergent Adverse Events | Through study completion, an average of 2 years |