MedTrace Logo

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

NCT05278221 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-03-10

No results posted yet for this study

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.

Conditions

  • Focal Epilepsy

Interventions

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

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2023-12-31
Completion
2024-03-31

Countries

  • Greece

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05278221 on ClinicalTrials.gov