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PHArmacotherapy Assessed Using Neuroprobing With TransOsseal Magnetic Stimulation (PHANTOMS)

I

Insel Gruppe AG, University Hospital Bern

Status

Enrolling

Conditions

Epilepsy

Treatments

Other: TMS-EEG

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Cecilia Friedrichs-Maeder, MD, MSc.; Maxime Baud, MD-Phd

Data sourced from clinicaltrials.gov

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