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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amyloid-positive MCI | Active Comparator | The subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol. |
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| Amyloid-negative MCI | Active Comparator | The subjects will receive active stimulation of standard intermittent TBS (iTBS) protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBS for Amyloid-positive MCI | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mini-Mental State Examination ( MMSE ) | Change from baseline Mini-Mental State Examination total scores immediately after TBS intervention | Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS |
| Montreal Cognitive Assessment | Change from baseline Montreal Cognitive Assessment total scores immediately after TBS intervention | Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS |
| Measure | Description | Time Frame |
|---|---|---|
| The standard uptake values changes of FDG-PET | The standard uptake values (SUV) changes of cerebral glucose metabolism using 18F-FDG-PET | Before and immediately after TBS intervention |
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Inclusion Criteria:
Exclusion Criteria:
Withdrawal criteria
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| Name | Affiliation | Role |
|---|---|---|
| KUAN YI WU | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Taoyuan | Taiwan |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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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.
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| TBS for Amyloid-negative MCI | Device | 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. |
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