NCT06892457 PHArmacotherapy Assessed Using Neuroprobing With TransOsseal Magnetic Stimulation
| NCT ID | NCT06892457 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Epilepsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-10-21 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Cecilia Friedrichs-Maeder, MD, MSc.
PRINCIPAL INVESTIGATOR
Bern University Hospital
Frequently Asked Questions
Who can join the NCT06892457 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06892457 currently recruiting?
Yes, NCT06892457 is actively recruiting participants. Contact the research team at cecilia.friedrichs-maeder@insel.ch for enrollment information.
Where is the NCT06892457 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT06892457 clinical trial?
NCT06892457 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Cecilia Friedrichs-Maeder, MD, MSc. at Bern University Hospital. The trial plans to enroll 40 participants.
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