Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-29 @ 5:20 PM
Study NCT ID:
NCT05448768
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-08
First Post:
2022-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, we will give two sessions of iTBS separated by 15 min.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2022-06-27', 'studyFirstSubmitQcDate': '2022-07-05', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mini-Mental State Examination ( MMSE )', 'timeFrame': 'Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS', 'description': 'Change from baseline Mini-Mental State Examination total scores immediately after TBS intervention'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': 'Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS', 'description': 'Change from baseline Montreal Cognitive Assessment total scores immediately after TBS intervention'}], 'secondaryOutcomes': [{'measure': 'The standard uptake values changes of FDG-PET', 'timeFrame': 'Before and immediately after TBS intervention', 'description': 'The standard uptake values (SUV) changes of cerebral glucose metabolism using 18F-FDG-PET'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mild Cognitive Impairment', 'theta-burst stimulation', 'repetitive transcranial magnetic stimulation (rTMS)'], 'conditions': ['Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'This study aims to examine the effects and potential mechanisms of theta-burst stimulation (TBS) on cognitive function in individuals with mild cognitive impairment (MCI).', 'detailedDescription': 'The investigators apply the NIA-AA criteria to subtype different endophenotypes of biomarker-defined MCI individuals. This is a prospective, open-label clinical trial, and combined functional neuroimaging study of 18F-FDG-PET to further explore the potential mechanisms. A total of 80 MCI patients will be consecutively recruited and be subjected to iTBS for 5 daily interventions per week for two consecutive weeks. Cognitive evaluation will be performed before and immediately after TBS intervention, and 8 weeks after TBS. Data on functional neuroimaging will be also collected before and after TBS protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects aged 50-90 year\n2. Subjects meet Petersen's criteria for mild cognitive impairment (Petersen, Smith et al. 1999)\n3. The CDR of MCI patients can be 0-0.5\n4. Amyloid PET should ever be performed\n\nExclusion Criteria:\n\n1. Any subject has a definite diagnosis of epilepsy or history of seizure attack.\n2. Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor.\n3. Any subject has clinically significant or unstable medical diseases including metabolic, renal,liver, lung or cardiovascular disorders including metabolic, renal, liver, lung or cardiovascular disorders.\n4. Any subject has current alcohol or other substances abuse and/ or dependence within the recent one year, or prolonged history of major psychiatric disorder like schizophrenia,bipolar disorder, and previously prolonged substances abuse.\n5. Any females who is pregnant or lactating.\n6. General MRI, TMS and/or PET exclusion criteria including subjects who had received brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or other metal devices/ objects that are not MR compatible in the body.\n\nWithdrawal criteria\n\n1. Complications onset after intervention that affect efficacy and safety judgments.\n2. New onset or progression of disease that may affect outcomes.\n3. Use of other therapies or drugs during the intervention period to change cognitive functions.\n4. Any subjects who are recognized as high risk of adverse effects by principle investigator."}, 'identificationModule': {'nctId': 'NCT05448768', 'briefTitle': 'Cognitive Effects and Potential Mechanisms of TBS in Subjects With MCI', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Biomarker-based Prediction of Cognitive Effects and Potential Mechanisms of Theta-burst Stimulation (TBS) in Subjects With Mild Cognitive Impairment (MCI)', 'orgStudyIdInfo': {'id': '202102037A3A0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amyloid-positive MCI', 'description': 'The subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol.', 'interventionNames': ['Device: TBS for Amyloid-positive MCI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Amyloid-negative MCI', 'description': 'The subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol.', 'interventionNames': ['Device: TBS for Amyloid-negative MCI']}], 'interventions': [{'name': 'TBS for Amyloid-positive MCI', 'type': 'DEVICE', 'description': 'The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.', 'armGroupLabels': ['Amyloid-positive MCI']}, {'name': 'TBS for Amyloid-negative MCI', 'type': 'DEVICE', 'description': 'The investigators will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, The investigators will give two sessions of iTBS separated by 15 min.', 'armGroupLabels': ['Amyloid-negative MCI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'KUAN YI WU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}