Mild Cognitive Impairment
Conditions
Keywords
Mild Cognitive Impairment, theta-burst stimulation, repetitive transcranial magnetic stimulation (rTMS)
Brief summary
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).
Detailed description
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.
Interventions
DEVICETBS for Amyloid-positive MCI
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.
DEVICETBS for Amyloid-negative MCI
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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model 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, we will give two sessions of iTBS separated by 15 min.
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects aged 50-90 year 2. Subjects meet Petersen's criteria for mild cognitive impairment (Petersen, Smith et al. 1999) 3. The CDR of MCI patients can be 0-0.5 4. Amyloid PET should ever be performed
Exclusion criteria
1. Any subject has a definite diagnosis of epilepsy or history of seizure attack. 2. Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor. 3. 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. 4. 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. 5. Any females who is pregnant or lactating. 6. General MRI, TMS and/or PET
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mini-Mental State Examination ( MMSE ) | Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS | Change from baseline Mini-Mental State Examination total scores immediately after TBS intervention |
| Montreal Cognitive Assessment | Baseline and immediately after 2 weeks of TBS and 8-week follow-up after TBS | Change from baseline Montreal Cognitive Assessment total scores immediately after TBS intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The standard uptake values changes of FDG-PET | Before and immediately after TBS intervention | The standard uptake values (SUV) changes of cerebral glucose metabolism using 18F-FDG-PET |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORKUAN YI WU
Chang Gung Memorial Hospital
Outcome results
None listed