EpilepsyPHANTOMSNCT06892457
PHArmacotherapy Assessed Using Neuroprobing With TransOsseal Magnetic Stimulation
An observational study of Epilepsy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- TMS-EEG
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Oct 2024to Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥ 18j) with epilepsy receiving a prescription for an anti-seizure medication for clinical reasons.
Who may be able to join
- Adult patients (≥ 18j) with epilepsy receiving a prescription for an anti-seizure medication for clinical reasons
- Written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Bern
Bern, 3010
Cecilia Friedrichs-Maeder, +41793944463, cecilia.friedrichs-maeder@insel.ch
About this study
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:
- Does the magnitude of transcranial magnetic stimulation (TMS)-evoked potentials (TEPs) measured with electroencephalography (EEG) change between OFF and ON medication states?
- 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.
- Conditions
- Epilepsy
- Being tested
- TMS-EEG
- Keywords
- Brain Excitability, Anti-Seizure Medication, Transcranial Magnetic Stimulation
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS-EEGOther
Evoked brain activity is measured with the help of TMS-EEG in epilepsy patients OFF and ON medication.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (1)
Persistence of TEP changes over time.
Number of participants with persistence of TEP changes over time.
Measured: 1-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start21 Oct 2024
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cecilia Friedrichs-Maeder, MD, MSc., Principal investigator, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892457
- Sponsor's protocol ID
- 5958
- Acronym
- PHANTOMS
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHArmacotherapy Assessed Using Neuroprobing With TransOsseal Magnetic Stimulation
- ClinicalTrials.gov ID
- NCT06892457
- Acronym / sponsor ID
- PHANTOMS / 5958
- Conditions
- Epilepsy
- Keywords
- Brain Excitability, Anti-Seizure Medication, Transcranial Magnetic Stimulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the magnitude of transcranial magnetic stimulation (TMS)-evoked potentials (TEPs) measured with electroencephalography (EEG) change between OFF and ON medication states?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥ 18j) with epilepsy receiving a prescription for an anti-seizure medication for clinical reasons.
Key inclusion criteria (2 listed)
- Adult patients (≥ 18j) with epilepsy receiving a prescription for an anti-seizure medication for clinical reasons
- Written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMS-EEGEvoked brain activity is measured with the help of TMS-EEG in epilepsy patients OFF and ON medication. | Other | – |
Primary outcome
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.
1 secondary outcome
Persistence of TEP changes over time.
Time frame: 1-6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cecilia Friedrichs-Maeder, MD, MSc. principal investigator
Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cecilia Friedrichs-Maeder, MD, MSc. (+41 79 394 44 63, cecilia.friedrichs-maeder@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TEP magnitude (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.