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NCT Number: NCT06892457

PHArmacotherapy Assessed Using Neuroprobing With TransOsseal Magnetic Stimulation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Bern

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Cecilia Friedrichs-Maeder

CONTACT

[email protected]

+41793944463

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TMS-EEG

Other

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

Primary outcomes

  1. Change in TEP magnitude

    Time frame: 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 outcomes

  1. Persistence of TEP changes over time.

    Time frame: 1-6 months

    Number of participants with persistence of TEP changes over time.

Study contacts

Contact information is provided by the study sponsor or research team.

Cecilia Friedrichs-Maeder, MD, MSc.

CONTACT

[email protected]

+41 79 394 44 63

Maxime Baud, MD-Phd

CONTACT

[email protected]

+41 79 385 96 90

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Acronym: PHANTOMS

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Mar 24, 2025
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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