Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-29 @ 5:12 AM
Study NCT ID:
NCT06892457
Status:
RECRUITING
Last Update Posted:
2025-03-24
First Post:
2025-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PHArmacotherapy Assessed Using Neuroprobing With TransOsseal Magnetic Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2025-03-21', 'studyFirstSubmitQcDate': '2025-03-21', 'lastUpdatePostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in TEP magnitude', 'timeFrame': '1 day', 'description': 'Whether the magnitude of measured TMS-evoked potentials (TEPs), measured as the line-length, is reduced between the OFF and ON ASM conditions.'}], 'secondaryOutcomes': [{'measure': 'Persistence of TEP changes over time.', 'timeFrame': '1-6 months', 'description': 'Number of participants with persistence of TEP changes over time.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Brain Excitability', 'Anti-Seizure Medication', 'Transcranial Magnetic Stimulation'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': "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:\n\n1. Does the magnitude of transcranial magnetic stimulation (TMS)-evoked potentials (TEPs) measured with electroencephalography (EEG) change between OFF and ON medication states?\n2. 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.\n\nParticipants will undergo one TMS-EEG session scheduled around their prescribed ASM (re)start and one 1-6 months later."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (≥ 18j) with epilepsy receiving a prescription for an anti-seizure medication for clinical reasons.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥ 18j) with epilepsy receiving a prescription for an anti-seizure medication for clinical reasons\n* Written informed consent\n\nExclusion Criteria:\n\n* Presence of any electrical implants (e.g. neurostimulator or drug delivery system) or any metallic implants anywhere in the head (excluding teeth)\n* Increased intracranial pressure\n* Uncontrolled psychiatric disorder\n* Use of any kind of drug or alcohol, nicotine allowed\n* For female participants: If pregnancy cannot be ruled out with sufficient certainty, a pregnancy test (urine) will be carried out before using TMS\n* Inability to give consent'}, 'identificationModule': {'nctId': 'NCT06892457', 'acronym': 'PHANTOMS', 'briefTitle': 'PHArmacotherapy Assessed Using Neuroprobing With TransOsseal Magnetic Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'Insel Gruppe AG, University Hospital Bern'}, 'officialTitle': 'PHArmacotherapy Assessed Using Neuroprobing With TransOsseal Magnetic Stimulation', 'orgStudyIdInfo': {'id': '5958'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TMS-EEG', 'type': 'OTHER', 'description': 'Evoked brain activity is measured with the help of TMS-EEG in epilepsy patients OFF and ON medication.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Cecilia Friedrichs-Maeder', 'role': 'CONTACT', 'email': 'cecilia.friedrichs-maeder@insel.ch', 'phone': '+41793944463'}], 'facility': 'University Hospital Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'centralContacts': [{'name': 'Cecilia Friedrichs-Maeder, MD, MSc.', 'role': 'CONTACT', 'email': 'cecilia.friedrichs-maeder@insel.ch', 'phone': '+41 79 394 44 63'}, {'name': 'Maxime Baud, MD-Phd', 'role': 'CONTACT', 'email': 'maxime.baud.neuro@gmail.com', 'phone': '+41 79 385 96 90'}], 'overallOfficials': [{'name': 'Cecilia Friedrichs-Maeder, MD, MSc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bern University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}