Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-26 @ 4:21 AM
Study NCT ID:
NCT04560959
Status:
UNKNOWN
Last Update Posted:
2020-09-23
First Post:
2020-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atlas of Intracranial Recordings on Cortical Responses After Functional tACS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-17', 'studyFirstSubmitDate': '2020-08-07', 'studyFirstSubmitQcDate': '2020-09-17', 'lastUpdatePostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of intracranial activities', 'timeFrame': 'Within 250 ms immediately after the stimulation.', 'description': 'The change of the power in a band of 0-200 HZ according to the intracranial EEG recording.'}], 'secondaryOutcomes': [{'measure': 'Frequency of the epileptic discharges', 'timeFrame': '50 minutes during the stimulation and 50 minutes of the interictal baseline before the intervention during the same hour of the day', 'description': 'To count the numbers of epileptic discharges within the same duration before and when tACS intervention.'}, {'measure': 'Event related potential (ERP)', 'timeFrame': 'Baseline: 24 hours before the tACS intervention; Observation: Immediately after the end of the tACS intervention.', 'description': 'ERP related to cognitive tasks before and immediately after the tACS intervention'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Transcranial Alternating Current Stimulation']}, 'referencesModule': {'references': [{'pmid': '37468529', 'type': 'DERIVED', 'citation': 'Shan Y, Wang H, Yang Y, Wang J, Zhao W, Huang Y, Wang H, Han B, Pan N, Jin X, Fan X, Liu Y, Wang J, Wang C, Zhang H, Chen S, Liu T, Yan T, Si T, Yin L, Li X, Cosci F, Zhang X, Zhang G, Gao K, Zhao G. Evidence of a large current of transcranial alternating current stimulation directly to deep brain regions. Mol Psychiatry. 2023 Dec;28(12):5402-5410. doi: 10.1038/s41380-023-02150-8. Epub 2023 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'By analyzing the SEEG recordings, we explore the range of cortical functional responses to strings of 77.5Hz stimulations delivered by tACS,'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All epileptic patients that would receive the implantation of SEEG electrodes, regardless of the seizure locations;\n* There was no metal implantation before;\n* Eligible for MRI examination;\n* No other lesional neurological disorders;\n* Could be well informed by the study protocols.\n\nExclusion Criteria:\n\n* Suffered from any other mental illnesses prior to the enrollment;\n* Those suffering from the serious or unstable organic diseases;\n* Pregnant or lactation women, and those who have a plan of pregnant;\n* Patients with central nervous system tumors, acute brain injury or infection;\n* Skin injured, or allergic to the exposure of the conductive gel;\n* Those with implanted devices;\n* Those who received modified electrical convulsive therapy, or TMS within the recent one month;\n* The score of item 3 (suicidal item) in HAMD-17 equal or greater than 3;\n* Enrolled in any other on going trials;\n* Other situations evaluated by the researchers as inappropriate to the enrollment'}, 'identificationModule': {'nctId': 'NCT04560959', 'acronym': 'AIRCRAFT', 'briefTitle': 'Atlas of Intracranial Recordings on Cortical Responses After Functional tACS', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'An Atlas of Cerebral Responses to the Stimuli of the tACS Recorded by SEEG', 'orgStudyIdInfo': {'id': 'LYS-[2020]-051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tACS arm', 'description': 'The patient would receive strings of tACS stimulations in 77.5 HZ, each string would last for 1 second, followed by an interval of 5 seconds. A total of 600 strings would be sent out to the patients.', 'interventionNames': ['Device: tACS']}], 'interventions': [{'name': 'tACS', 'type': 'DEVICE', 'description': 'tACS would be performed to epilepsy patients who have already received implantation of the SEEG electrodes', 'armGroupLabels': ['tACS arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'P.H. Wei', 'role': 'CONTACT', 'email': 'weipenghu@xwhosp.org', 'phone': '+86-010-83198252'}], 'overallOfficials': [{'name': 'G.G. Zhao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurosurgery, Capital Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}