Investigating how anti-seizure medications affect brain excitability in epilepsy patients
PHArmacotherapy Assessed Using Neuroprobing With TransOsseal Magnetic Stimulation
Insel Gruppe AG, University Hospital Bern · NCT06892457
This study is testing how anti-seizure medications change brain activity in adults with epilepsy by comparing measurements taken when they are on the medication to when they are not.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern (other) |
| Locations | 1 site (Bern) |
| Trial ID | NCT06892457 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the impact of prescribed anti-seizure medications on cortical excitability in adults diagnosed with epilepsy. Participants will undergo transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) to measure TMS-evoked potentials (TEPs) during two sessions: one scheduled around the start of their medication and another 1-6 months later. The study will compare TEP measurements in participants when they are on medication versus when they are off medication to assess any changes in brain excitability over time.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been prescribed anti-seizure medications for their epilepsy.
Not a fit: Patients with electrical or metallic implants in their head, uncontrolled psychiatric disorders, or those unable to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how anti-seizure medications influence brain activity, potentially leading to improved treatment strategies for epilepsy.
How similar studies have performed: While the approach of using TMS-EEG to assess brain excitability in relation to medication effects is innovative, similar studies have shown promise in understanding brain function in epilepsy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bern
- University Hospital Bern — Bern, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Cecilia Friedrichs-Maeder, MD, MSc. — Bern University Hospital
- Study coordinator: Cecilia Friedrichs-Maeder, MD, MSc.
- Email: cecilia.friedrichs-maeder@insel.ch
- Phone: +41 79 394 44 63
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy, Brain Excitability, Anti-Seizure Medication, Transcranial Magnetic Stimulation