TMS Combined With EEG/EMG as a Biomarker Predicting Antiepileptic Drug

Status Recruiting

Clinical Trial Summary

Ιn the present study (BIOEPI), the following three hypotheses will be investigated: 1. The proposed TMS-EEG / EMG protocol (which includes software for calculating the cerebral cortex stimulation threshold) in combination with advanced signal analysis and data mining methods will allow the detection of the effect of antiepileptic drugs (AED) with different mechanisms of action (lacosamide & brivaracetam) in the Central Nervous System under healthy and pathological conditions (Epilepsy). 2. AED-induced changes in selected TMS-EEG / EMG features predict the clinical response of individual epileptic patients to AED. 3. AED-induced changes in selected TMS-EEG / EMG features may predict cognitive side effects.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05278221
Study type	Interventional
Source	Aristotle University Of Thessaloniki
Contact	Vasilios Kimiskidis, Professor
Phone	+30-2310-994667
Email	kimiskid@auth.gr
Status	Recruiting
Phase	N/A
Start date	August 1, 2022
Completion date	March 31, 2024

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

TMS Combined With EEG/EMG as a Biomarker Predicting Antiepileptic Drug Response — BIOEPI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms