Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
Study NCT ID:
NCT06716866
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-20
First Post:
2024-10-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2024-10-25', 'studyFirstSubmitQcDate': '2024-11-29', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of Interictal Biomarkers of Epilepsy', 'timeFrame': 'From enrollment until the end of the admission for each patient (the admission is typically 7-14 days in duration).', 'description': "Three epilepsy interictal biomarkers will be examined: Interictal epileptiform discharges (IEDs), pathologic ripples (PRs), and high-frequency oscillations (HFOs). Each is recorded from intracranial field potential recordings (also 'intracranial electroencephalography' or iEEG). IEDs can also be recorded from scalp EEG where this is available (it is typically not recorded during iEEG studies). These features of the intracranial EEG will be measured at baseline, during sham TIEFS, and during active TIEFS.\n\nThe primary outcome is the change in the number of IEDs during the baseline, sham, or active TIEFS periods. The secondary outcome is the number of PRs and HFOs during these periods.\n\nSemi-automated detection of IEDs, PRs, and HFOs will be performed using the freely available and validated AnyWave software ( INSERM and Aix-Marseille University) and its 'Delphos' detector. IEDs, PRs, and HFOs rates per minute will be determined."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['temporally-interfering electric fields'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'This study investigates the potential for temporally-interfering electric field stimulation (TIEFS) to treat epilepsy. In this case series within and between subjects design, the impact of TIEFS on epilepsy biomarkers was studied in patients with medial temporal lobe epilepsy.\n\nSecondary analyses examine the underlying physiological effects of TIEF on local brain activity and brain networks.', 'detailedDescription': 'Participants Patients with drug-resistant focal epilepsy and a clinical diagnosis of medial temporal epilepsy undergoing invasive intracranial electrophysiology studies will be consented in accord with institutional review boards at Emory University, Saint-Anne University Hospital, and the Institute of Neurosurgery and Neurointervention, Semmelweis University. The determination of medial temporal epilepsy is based on clinical semiology, EEG, PET, MRI, and invasive electrophysiology. Across all centers, patients underwent the stimulation protocols 6 to 10 days post-implantation after patient-specific electric field modeling to determine TIEFS electrode placement.\n\nPatients then undergo two sessions of TIEFS on separate days, one sham (aligned carriers), and one active (with an offset in frequency between the carriers to provide a lower-frequency modulation envelope at the anatomical target.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing invasive intracranial EEG studies\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06716866', 'acronym': 'EE-DES-TIEF', 'briefTitle': 'Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy - Effect of Temporal Interference on Biomarkers of Epilepsy', 'orgStudyIdInfo': {'id': '2042345'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Temporally-Interfering Electrical Field Central Nervous System Stimulation', 'description': 'Participants in this arm receive temporally-interfering electric fields stimulation.', 'interventionNames': ['Device: temporally-interfering electric field stimulation']}], 'interventions': [{'name': 'temporally-interfering electric field stimulation', 'type': 'DEVICE', 'otherNames': ['temporal interference electric field stimulation'], 'description': 'Temporally-interfering electric field stimulation is a candidate non-invasive means to stimulate and modulate the nervous system. We do not know of any other trials of this method in epilepsy patients.', 'armGroupLabels': ['Temporally-Interfering Electrical Field Central Nervous System Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'St. Anne Hospital, Masaryk University', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'At the completion of the studies.', 'ipdSharing': 'YES', 'description': 'Deidentified IPD will be shared with other researchers at the completion of the study.\n\nIPD in this study consists of the anatomical location of electrode contacts, electrophysiological recordings, field models of the carrier fields and interference envelope. IPD also includes neuroimaging, and key data from the clinical neurophysiology reports.\n\nAll data will be fully de-identified.', 'accessCriteria': 'Data will be shared upon request to the investigative team for non-commercial and academic use.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Emory University', 'class': 'OTHER'}, {'name': "St. Anne's University Hospital Brno, Czech Republic", 'class': 'OTHER'}, {'name': 'Semmelweis University', 'class': 'OTHER'}, {'name': 'Hôpital de la Timone (MARSEILLE)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}