Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2026-01-02 @ 4:53 AM
Study NCT ID:
NCT06663969
Status:
RECRUITING
Last Update Posted:
2025-02-05
First Post:
2024-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Modulation Effects of Temporal Interference Using SEEG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'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': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2024-10-26', 'studyFirstSubmitQcDate': '2024-10-26', 'lastUpdatePostDateStruct': {'date': '2025-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electrophysiological changes', 'timeFrame': 'During the trial(up to 3 hours for each subject)', 'description': 'Electrophysiological waveform changes recorded by stereoelectroencephalography (SEEG) before, during, and after TI stimulation.'}], 'secondaryOutcomes': [{'measure': "Patient's subjective feelings and symptoms", 'timeFrame': 'During the trial(up to 3 hours for each subject)', 'description': "Researchers categorized patients' clinical responses as normal, mild, moderate, or severe based on their subjective clinical response."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Temporal Interference', 'Stereoelectroencephalography', 'Drug Resistant Epilepsy'], 'conditions': ['Deep Brain Stimulation', 'Drug Resistant Epilepsy']}, 'descriptionModule': {'briefSummary': 'This single-center prospective study aims to investigate the electrophysiological mechanisms of temporal interference (TI) in humans by analyzing clinical, imaging, and electrophysiological data from patients aged 14-60 with drug-resistant epilepsy.', 'detailedDescription': "Temporal Interference (TI) technology is a novel non-invasive method for deep brain stimulation (DBS). By generating an overlapping electric field from safe currents, TI creates focused stimulation in targeted deep brain areas. This approach allows for the exploration of deep brain nuclei functions and has the potential to serve as a non-invasive alternative to traditional invasive DBS for clinical treatments.\n\nStereoelectroencephalography (SEEG) is a method for recording electrical activity from deep brain structures using implanted depth electrodes to provide a three-dimensional view of neuronal activity.\n\nThis study aims to investigate the electrophysiological mechanisms of temporal interference (TI) deep brain stimulation by including patients aged 14-60 with implanted intracranial electrodes. During and after TI stimulation, electrophysiological and clinical data will be recorded. Clinical, imaging, and electrophysiological data will be analyzed and processed to advance understanding of TI's effects in deep brain stimulation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of drug-resistant epilepsy;\n* No severe systemic diseases;\n* Implantation of stereotactic electrodes;\n* Agreement to participate in this study and signs the informed consent form.\n\nExclusion Criteria:\n\n* Hematoma at the scalp electrode site or fluid accumulation under the electrode after intracranial electrode placement.'}, 'identificationModule': {'nctId': 'NCT06663969', 'briefTitle': 'Evaluating Modulation Effects of Temporal Interference Using SEEG', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Evaluating Modulation Effects of Temporal Interference Using SEEG', 'orgStudyIdInfo': {'id': '2024-258-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Temporal Interference', 'description': 'The investigators performed temporal interference (TI) stimulation to patients with drug-resistant epilepsy undergoing SEEG monitoring. They observed electrophysiological activity and clinical manifestations before, during, and after stimulation to investigate the electrophysiological mechanisms of TI.', 'interventionNames': ['Other: Temporal Interference']}], 'interventions': [{'name': 'Temporal Interference', 'type': 'OTHER', 'description': 'Researchers applied temporal interference (TI) stimulation to the deep brain nuclei of patients who had undergone SEEG monitoring, recording changes in electrical activity detected by SEEG.', 'armGroupLabels': ['Temporal Interference']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liankun Ren, MD', 'role': 'CONTACT', 'email': 'renlk2022@outlook.com', 'phone': '+86 13681576621'}, {'name': 'Liankun Ren, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xuanwu Hospital,Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Liankun Ren, MD', 'role': 'CONTACT', 'email': 'renlk2022@outlook.com', 'phone': '+86 13681576621'}, {'name': 'Ren, MD', 'role': 'CONTACT', 'email': 'renlk2022@outlook.com', 'phone': '+86 13681576621'}], 'overallOfficials': [{'name': 'Liankun Ren, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuanwu Hospital, Beijing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Liankun_Ren', 'investigatorAffiliation': 'Xuanwu Hospital, Beijing'}}}}