PHArmacotherapy Assessed Using Neuroprobing With TransOss... | NCT06892457

Studies
PHArmacotherapy Assessed Using Neuroprobing With TransOsseal Magnetic Stimulation

NCT06892457

Sponsor

Insel Gruppe AG, University Hospital Bern

Status

Recruiting

Last Update Posted

Mar 24, 2025Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Epilepsy

Interventions

TMS-EEG

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 21, 2024Actual

Primary Completion Date

Oct 2029Estimated

Completion Date

Oct 2029Estimated

First Submitted Date

Mar 21, 2025

First Submission Date that Met QC Criteria

Mar 21, 2025

First Posted Date

Mar 24, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2025

Last Update Posted Date

Mar 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TMS-EEG	Other	Evoked brain activity is measured with the help of TMS-EEG in epilepsy patients OFF and ON medication.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 day

Secondary Outcomes

Measure	Description	Time Frame
Persistence of TEP changes over time.	Number of participants with persistence of TEP changes over time.	1-6 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients (≥ 18j) with epilepsy receiving a prescription for an anti-seizure medication for clinical reasons.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Cecilia Friedrichs-Maeder, MD, MSc.	Contact	+41 79 394 44 63		cecilia.friedrichs-maeder@insel.ch
Maxime Baud, MD-Phd	Contact	+41 79 385 96 90		maxime.baud.neuro@gmail.com

Overall Officials

Name	Affiliation	Role
Cecilia Friedrichs-Maeder, MD, MSc.	Bern University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Bern	Recruiting	Bern		3010	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004827	Epilepsy

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided