NCT05278221

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

Development and Optimization of Transcranial Magnetic Stimulation (TMS) Combined With EEG/EMG as a Biomarker Predicting Response to Antiepileptic Drugs

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Aristotle University Of Thessaloniki · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Focal Epilepsy

Interventions

Type	Name	Description
DEVICE	Software EstimLT	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

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-12-31
• Completion: 2024-03-31
• First posted: 2022-03-14
• Last updated: 2023-03-10

Locations

1 site across 1 country: Greece