Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06670820
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-01
First Post:
2024-10-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ITBS in MCI and Mild AD
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in neurocognitive function test scores (Mini-Mental State Examination；MMSE) between T1 (Day 1) and T2 (Day 14), and the differences between the experimental and control groups.', 'timeFrame': 'MMSE will be controlled at baseline before active or sham rTMS, 2 weeks after active and sham rTMS, 3 months after the last treatment', 'description': 'The mini-mental state examination (MMSE) test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.The MMSE is a standardized cognitive screening test with a possible score of 0-30. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.'}], 'secondaryOutcomes': [{'measure': 'Changes in neurocognitive function test scores (Mini-Mental State Examination；MMSE) between T1(Day 1) and T3 (98 ± 14), and the differences between the experimental and control groups.', 'timeFrame': 'MMSE will be controlled at baseline (T1: Day 1) before active or sham rTMS, 2 weeks after active and sham rTMS (T2: Day 17 ± 5), 3 months after the last treatment (T3: Day 98 ± 14).', 'description': 'The mini-mental state examination (MMSE) test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.The MMSE is a standardized cognitive screening test with a possible score of 0-30. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.'}, {'measure': 'Changes in blood BDNF concentration levels before and after active rTMS and after sham rTMS, as well as the differences between the experimental group and the control group', 'timeFrame': 'BDNF will be controlled at baseline ( Day 1) before active or sham rTMS, 2 weeks after active and sham rTMS (Day 17 ± 5).'}, {'measure': 'Side effects between the two groups.', 'timeFrame': 'Side effects will be monitored during 2 groups (active and sham) through study completion, an average of 3-4 months.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rTMS', 'iTBS', 'Mild Cognitive Impairment', 'Mild Alzheimer Disease'], 'conditions': ['Mild Cognitive Impairment (MCI)', 'Mild Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '24833712', 'type': 'BACKGROUND', 'citation': 'Daskalakis ZJ. Theta-burst transcranial magnetic stimulation in depression: when less may be more. Brain. 2014 Jul;137(Pt 7):1860-2. doi: 10.1093/brain/awu123. Epub 2014 May 15. No abstract available.'}, {'pmid': '15664172', 'type': 'BACKGROUND', 'citation': 'Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/24833712/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study aims to examine the effects of iTBS on cognitive function in individuals with MCI or mild AD, with a secondary objective of exploring prefrontal TBS mechanisms for cognitive function and the effect of iTBS on BDNF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of MCI (overall Clinical Dementia Rating of 0.5)\n* Clinical diagnosis of mild Alzheimer's Disease (overall Clinical Dementia Rating of 0.5 or 1)\n\nExclusion Criteria:\n\n* History of stroke\n* History of uncontrol seizure\n* History of significant head trauma followed by persistent neurologic deficit or known structural brain abnormality\n* Mental illness\n* Drug abuse"}, 'identificationModule': {'nctId': 'NCT06670820', 'briefTitle': 'ITBS in MCI and Mild AD', 'organization': {'class': 'OTHER', 'fullName': 'National Defense Medical Center, Taiwan'}, 'officialTitle': "The Effects of Intermittent Theta-burst Stimulation on Cognitive Function in Patients with Mild Cognitive Impairment and Mild Alzheimer's Disease and the Role of Brain-Derived Neurotrophic Factor", 'orgStudyIdInfo': {'id': 'A202305164'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active iTBS for Patients With MCI or AD', 'description': 'The patient will receive one daily rTMS session for 10 days of iTBS, delivered through an H-coil applied to the left dorsolateral prefrontal cortex. The TBS frequency parameters consist of 3-pulse 50-Hz bursts every 200 ms at 5 Hz, and the intensity will be set at 80% of the active motor threshold (AMT). A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times.', 'interventionNames': ['Device: Active rTMS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham iTBS for Patients With MCI or AD', 'description': 'Sham stimulation will be delivered 10 sessions.', 'interventionNames': ['Device: Sham rTMS']}], 'interventions': [{'name': 'Active rTMS', 'type': 'DEVICE', 'description': 'iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total10 sessions', 'armGroupLabels': ['Active iTBS for Patients With MCI or AD']}, {'name': 'Sham rTMS', 'type': 'DEVICE', 'description': 'sham iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total 10 sessions', 'armGroupLabels': ['Sham iTBS for Patients With MCI or AD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'state': 'Other', 'country': 'Taiwan', 'contacts': [{'name': 'Yu-Kai Lin', 'role': 'CONTACT', 'email': 'yukai0907@ndmctsgh.edu.tw', 'phone': '886-2-87923311 ext 10552,13907'}, {'role': 'CONTACT', 'phone': '886-987-859-907'}], 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'YU-KAI LIN', 'role': 'CONTACT', 'email': 'yukai0907@ndmctsgh.edu.tw', 'phone': '886-987-859-907'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Defense Medical Center, Taiwan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Tri-Service General Hospital', 'investigatorFullName': 'Yu-Kai Lin', 'investigatorAffiliation': 'National Defense Medical Center, Taiwan'}}}}