PHArmacotherapy Assessed Using Neuroprobing With TransOsseal Magnetic Stimulation

NCT06892457 | Recruiting DMC

• 1 other identifier: 5958
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Does the magnitude of transcranial magnetic stimulation (TMS)-evoked potentials (TEPs) measured with electroencephalography (EEG) change between OFF and ON medication states?
2. 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.

Conditions

Epilepsy

Keywords

Brain Excitability; Anti-Seizure Medication; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Change in TEP magnitude

  Whether the magnitude of measured TMS-evoked potentials (TEPs), measured as the line-length, is reduced between the OFF and ON ASM conditions.

  1 day

Secondary Outcomes (1)

• Persistence of TEP changes over time.

  1-6 months

Interventions

TMS-EEG OTHER

Evoked brain activity is measured with the help of TMS-EEG in epilepsy patients OFF and ON medication.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Cecilia Friedrichs-Maeder, MD, MSc.

  Bern University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cecilia Friedrichs-Maeder, MD, MSc.

CONTACT

+41 79 394 44 63; cecilia.friedrichs-maeder@insel.ch

Maxime Baud, MD-Phd

CONTACT

+41 79 385 96 90; maxime.baud.neuro@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 24, 2025
• Study Start: October 21, 2024
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

CH (1)