Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-03-03 @ 2:58 AM
Study NCT ID:
NCT06941961
Status:
RECRUITING
Last Update Posted:
2025-04-30
First Post:
2025-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iTBS for Acute Ischemic Stroke After Thrombectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 178}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2025-04-15', 'studyFirstSubmitQcDate': '2025-04-22', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days', 'timeFrame': '90 days', 'description': 'Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Distribution of Modified Rankin Scale (mRS) Scores at 90 Days', 'timeFrame': '90 days', 'description': 'mRS scores (0-6) assess functional independence, where lower scores indicate better outcomes.'}, {'measure': 'Distribution of Modified Rankin Scale (mRS) Scores at 30 Days', 'timeFrame': '30 days', 'description': 'mRS scores (0-6) assess functional independence, where lower scores indicate better outcomes.'}, {'measure': 'Differences in National Institutes of Health Stroke Scale (NIHSS) Score at 7 days', 'timeFrame': '7 days', 'description': 'NIHSS (0-42) measures neurological deficit severity, with lower scores indicating better function.'}, {'measure': 'Proportion of Patients with Early Neurological Deterioration (END) Within 7 Days', 'timeFrame': '7 days', 'description': 'END is defined as an increase in NIHSS score ≥4 points from baseline.'}, {'measure': 'All-Cause Mortality Rate at 90 Days', 'timeFrame': 'From randomization to 90 days', 'description': 'Proportion of patients who died from any cause within 90 days.'}, {'measure': 'Incidence of Intracranial Hemorrhage (ICH) and Symptomatic ICH (sICH) During Intervention', 'timeFrame': '7 days', 'description': 'ICH is assessed via imaging'}, {'measure': 'Rate of iTBS-Related Adverse Events', 'timeFrame': 'From randomization to 90 days', 'description': 'Includes seizures, headache, scalp discomfort, or other stimulation-related AEs.'}, {'measure': 'Overall Adverse Event (AE) Rate', 'timeFrame': 'From randomization to 90 days', 'description': 'Proportion of patients experiencing any AE during the study.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized, single-blind, parallel-controlled clinical trial is to evaluate the efficacy and safety of intermittent theta burst stimulation (iTBS) as an adjunctive therapy for acute anterior circulation ischemic stroke patients who have undergone successful mechanical thrombectomy (MT). The study population includes adults aged 18-85 with NIHSS scores 5-25 post-MT and eTICI≥2b reperfusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Age 18-85 years, regardless of gender.\n* 2\\) Acute ischemic stroke caused by occlusion of the anterior circulation large vessels (internal carotid artery, M1 or M2 segment of the middle cerebral artery), verified by CTA or DSA.\n* 3\\) Mechanical thrombectomy (MT) performed within 24 hours of symptom onset.\n* 4\\) Successful Reperfusion: Post-MT eTICI score ≥ 2b.\n* 5\\) NIHSS score 5-25 at 24 hours post-MT, with ≥2 points in at least one limb.\n\nExclusion Criteria:\n\n* 1\\) Pre-stroke modified Rankin Scale (mRS) score ≥2.\n* 2\\) PH2-type intracranial hemorrhage on brain CT post-MT.\n* 3\\) Patients who underwent intracranial stent placement during MT.\n* 4\\) Contraindications to iTBS: History of epilepsy or seizures, implanted cardiac pacemakers, cochlear implants, or other electronic/magnetic-sensitive devices.\n* 5\\) Severe consciousness impairment, cognitive dysfunction, or psychiatric disorders preventing compliance with iTBS.\n* 6\\) Expected survival \\<3 months due to other medical conditions or inability to complete follow-up for any reason.\n* 7\\) Participation in another interventional study.\n* 8\\) Any other condition deemed unsuitable for enrollment by the investigator.'}, 'identificationModule': {'nctId': 'NCT06941961', 'briefTitle': 'iTBS for Acute Ischemic Stroke After Thrombectomy', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'Efficacy and Safety of Intermittent Theta Burst Stimulation in Acute Anterior Circulation Ischemic Stroke Patients Undergoing Mechanical Thrombectomy', 'orgStudyIdInfo': {'id': 'iTBS-ACT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'iTBS', 'description': 'Patients are treated with intermittent theta burst stimulation (iTBS).', 'interventionNames': ['Device: intermittent theta burst stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham-iTBS', 'description': 'Patients are treated with sham intermittent theta burst stimulation (sham-iTBS).', 'interventionNames': ['Device: sham intermittent theta burst stimulation']}], 'interventions': [{'name': 'intermittent theta burst stimulation', 'type': 'DEVICE', 'description': 'The iTBS delivered to the ipsilesional primary motor cortex (M1) at 80% resting motor threshold (RMT). Each session consists of 600 pulses (3-minute trains of 50 Hz triplets repeated every 10 seconds, twice daily with a 5-minute interval), administered for 7 consecutive days starting within 6 hours post-randomization.', 'armGroupLabels': ['iTBS']}, {'name': 'sham intermittent theta burst stimulation', 'type': 'DEVICE', 'description': 'Sham-iTBS is performed in the same way as the treatment group but uses 20% RMT.', 'armGroupLabels': ['sham-iTBS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130000', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi Yang, MD, PhD', 'role': 'CONTACT', 'email': 'doctor_yangyi@163.com', 'phone': '0086-13756661217'}], 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Yi Yang, MD, PhD', 'role': 'CONTACT', 'email': 'doctor_yangyi@163.com', 'phone': '0086-13756661217'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yi Yang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Vice President of First Hospital of Jilin University', 'investigatorFullName': 'Yi Yang', 'investigatorAffiliation': 'The First Hospital of Jilin University'}}}}