PHArmacotherapy Assessed Using Neuroprobing With TransOsseal Magnetic Stimulation

Recruiting

• Conditions: Epilepsy

• Registration Number: NCT06892457
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

Brief Summary

The goal of this observational study is to investigate how prescribed anti-seizure medications (ASMs) affect cortical excitability in adults with epilepsy. The main questions it aims to answer are:

1. Does the magnitude of transcranial magnetic stimulation (TMS)-evoked potentials (TEPs) measured with electroencephalography (EEG) change between OFF and ON medication states?

2. Do these changes in TEP amplitude persist over time? Researchers will compare each participant's measurements in the OFF state with those in the ON state to see if TEPs change following ASM (re)start.

Participants will undergo one TMS-EEG session scheduled around their prescribed ASM (re)start and one 1-6 months later.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-21
• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-21
• Last Update Submitted: 2025-03-21
• Study First Posted: 2025-03-24
• Last Update Posted: 2025-03-24
• Primary Completion: 2029-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult patients (≥ 18j) with epilepsy receiving a prescription for an anti-seizure medication for clinical reasons
• Written informed consent

Exclusion Criteria

• Presence of any electrical implants (e.g. neurostimulator or drug delivery system) or any metallic implants anywhere in the head (excluding teeth)
• Increased intracranial pressure
• Uncontrolled psychiatric disorder
• Use of any kind of drug or alcohol, nicotine allowed
• For female participants: If pregnancy cannot be ruled out with sufficient certainty, a pregnancy test (urine) will be carried out before using TMS
• Inability to give consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in TEP magnitude	1 day	Whether the magnitude of measured TMS-evoked potentials (TEPs), measured as the line-length, is reduced between the OFF and ON ASM conditions.

Secondary Outcome Measures

Name	Time	Method
Persistence of TEP changes over time.	1-6 months	Number of participants with persistence of TEP changes over time.

Trial Locations

Locations (1)

University Hospital Bern; 🇨🇭 Bern, Switzerland