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

This is an interventional diagnostic trial for Focal Epilepsy focused on measuring epilepsy, medical device Read More

Inclusion Criteria:

General criteria:

1. Adult volunteers aged 18-65 years
2. Able to provide informed consent
3. Meet the criteria of the attached TMS safety questionnaire (Rossi et al, 2011). It is clarified that: a) criterion 1 does not apply to the group of patients and b) a positive answer to criteria 5, 6, 8, 9 & 10 excludes inclusion in the study while the other answers are evaluated by the investigator.

Specific criteria:

The specific criteria per group of study participants are as follows:

Patient Group:

1. Adult patients, 18-65 years of age, suffering from focal epilepsy, as evidenced by clinical and EEG features.
2. All patients continue suffering from seizures despite treatment with 1-2 concomitant AEDs (with vagal nerve stimulation counting as an AED). In order to be eligible, patients should be suffering from simple partial seizures (SPS) and a motor component or complex partial seizures (CPS) with or without secondary generalization (sGS). Patients should report at least three seizures during the 12 weeks of Historical Baseline.
3. Patients are required to be Lacosamide and Brivaracetam-naive and, in the latter case, not taking concomitant Levetiracetam.
4. Patients are about to commence treatment with Lacosamide or Brivaracetam, as per the treating physician's orders. It is stressed that the decision to prescribe Lacosamide or Brivaracetam is made by the patient's treating physician totally independently from participation in the current study.
5. Epilepsies of genetic or unknown aetiology (patients with hippocampal sclerosis can be included). The epileptic patients will be a convenience sample recruited at the Epilepsy Outpatient Clinic of the University General Hospital of Thessaloniki "AHEPA".

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:

1. The presence of Central Nervous System "CNS" disorders other than epilepsy on history or examination
2. Comorbid psychiatric or medical conditions that may compromise the ability of the individuals to participate in the study
3. EEG evidence of generalized epilepsy.
4. Uncountable seizures due to clustering.
5. Use of centrally acting drugs other than AEDs.
6. Pregnancy or planned pregnancy prior to the index test.

Healthy control group:

1. Presence of medical or psychiatric conditions that may interfere with the procedures.
2. Contraindications to TMS (i.e. pregnancy, presence of heart pacemakers, metal objects etc).
3. History of adverse reactions to pharmacological agents.
4. History of alcohol or nicotine abuse or use of any other centrally acting drug.
5. Participation in another clinical trial in the previous 8 weeks.
6. Pregnancy or planned pregnancy prior to the index test.