Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2026-01-01 @ 1:54 PM
Study NCT ID:
NCT06667232
Status:
RECRUITING
Last Update Posted:
2025-01-22
First Post:
2024-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-18', 'studyFirstSubmitDate': '2024-10-27', 'studyFirstSubmitQcDate': '2024-10-29', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Modulation Factor', 'timeFrame': 'During the trial(up to 3 hours for each subject)', 'description': 'Investigators calculate normalized the Modulation Factors of single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation patterns using (stimulation-pre-stimulation)/(stimulation + pre-stimulation)'}, {'measure': 'EEG power in spectral frequency bands', 'timeFrame': 'During the trial(up to 3 hours for each subject)', 'description': 'Using SEEG-implanted electrodes, the investigators applied electrical stimulation single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation while observing and recording EEG power changes across six spectral frequency bands during the pre-stimulation, stimulation, and post-stimulation periods.\n\nEEG Frequency Bands delta (1-4 Hz) theta (5-8 Hz) alpha (9-12 Hz) beta (13-30 Hz) low gamma (31-70 Hz) high gamma (71-150 Hz)'}, {'measure': 'Phase Locking Value', 'timeFrame': 'During the trial(up to 3 hours for each subject)', 'description': 'To estimate functional connectivity through the oscillatory synchrony of two brain regions, phase locking value (PLV) provides a measure of inter-regional synchrony based on phase difference between the paired signals.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['burst stimulation patterns', 'epilepsy', 'SEEG'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate modulation effects of burst stimulation patterns via SEEG.', 'detailedDescription': 'Our research group plans to conduct a study on patients with drug-resistant epilepsy who have SEEG electrodes implanted. The study will evaluate and compare the modulation effect of single-pulse electrical stimulation, paired electrical stimulation, stepwise electrical stimulation, and burst electrical stimulation via direct electrical stimulation using SEEG. The goal is to explore the focal and network modulation effect of distinct stimulation paradigms during the resting state and post-seizure state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Drug-resistant focal epilepsy\n* Justified SEEG exploration in the context of presurgical assessment of epilepsy\n* Subjects will be a part of the epilepsy-monitoring unit for long-term SEEG recordings and analysis\n* Written non-opposition to study participation\n\nExclusion Criteria:\n\n* Pregnant women (Contraindication to SEEG exploration)\n* Psychiatric disorders\n* History of psychotic disorders\n* History of cranial trauma serious (according to the classification), previous or evolutionary other neurological pathology\n* Subjects that experience surgical complications during the implant procedure will be excluded from the study'}, 'identificationModule': {'nctId': 'NCT06667232', 'briefTitle': 'Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Evaluating Modulation Effects of Burst Stimulation Patterns Using SEEG', 'orgStudyIdInfo': {'id': '2024-173-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-pulse stimulation', 'description': 'Single pulse electrical stimulation (SPES) is an investigational direct electrical stimulation (DES) pattern. Direct cortical stimulation applied at a frequency of ∼1Hz can probe cortico-cortical connections by averaging electrocorticogram time-lock to the stimuli.', 'interventionNames': ['Other: Single-pulse stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Paired-pulse stimulation', 'description': 'Paired-pulse stimulation paradigm associates a conditioning and a test stimulation to induce intracortical inhibition or facilitation by modifying the response amplitude.', 'interventionNames': ['Other: Paired-pulse stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Stepwise frequency stimulation', 'description': 'Stepwise frequency stimulation is a DES protocol that incrementally increases the stimulation frequency, starting from a lower to higher.', 'interventionNames': ['Other: Stepwise frequency stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'Burst stimulation', 'description': 'Burst stimulation is a DES patterned repetitive stimulation method; it represents a "more precise" and "smarter" electrical stimulation paradigm. Within a group, high-frequency pulses are emitted, and between groups, low-frequency pulses are delivered. This pattern of pulse delivery more closely mimics the physiological activity of neurons within the brain.', 'interventionNames': ['Other: Burst stimulation']}], 'interventions': [{'name': 'Single-pulse stimulation', 'type': 'OTHER', 'description': 'Investigators use single-pulse electrical stimulations at 1Hz to elicit cortico-cortical evoked potentials', 'armGroupLabels': ['Single-pulse stimulation']}, {'name': 'Paired-pulse stimulation', 'type': 'OTHER', 'description': 'The repetitive delivery of pairs of stimulation pulses is DES patten with a 5-50 ms interval between each pulse, constitutes repetitive paired-pulse stimulation.', 'armGroupLabels': ['Paired-pulse stimulation']}, {'name': 'Stepwise frequency stimulation', 'type': 'OTHER', 'description': 'Stepwise incremental stimulation ranging from 5 Hz to 145 Hz following a cyclic pattern.', 'armGroupLabels': ['Stepwise frequency stimulation']}, {'name': 'Burst stimulation', 'type': 'OTHER', 'description': 'Burst stimulation pattern consisting of short bursts delivered once a second and an intraburst frequency of 50 Hz, 100 Hz, 150 Hz, 175 Hz and 200 Hz', 'armGroupLabels': ['Burst stimulation']}]}, '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'}], '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'}}}}