Mild Alzheimer Disease, Mild Cognitive Impairment (MCI)
Conditions
Keywords
rTMS, iTBS, Mild Cognitive Impairment, Mild Alzheimer Disease
Brief summary
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.
Interventions
DEVICEActive rTMS
iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total10 sessions
DEVICESham rTMS
sham iTBS targeting the left dorsolateral prefrontal cortex (DLPFC) per session, total 10 sessions
Sponsors
National Defense Medical Center, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of MCI (overall Clinical Dementia Rating of 0.5) * Clinical diagnosis of mild Alzheimer's Disease (overall Clinical Dementia Rating of 0.5 or 1)
Exclusion criteria
* History of stroke * History of uncontrol seizure * History of significant head trauma followed by persistent neurologic deficit or known structural brain abnormality * Mental illness * Drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | MMSE will be controlled at baseline before active or sham rTMS, 2 weeks after active and sham rTMS, 3 months after the last treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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). | 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. |
| 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 | BDNF will be controlled at baseline ( Day 1) before active or sham rTMS, 2 weeks after active and sham rTMS (Day 17 ± 5). | — |
| Side effects between the two groups. | Side effects will be monitored during 2 groups (active and sham) through study completion, an average of 3-4 months. | — |
Countries
Taiwan
Contacts
Primary ContactYU-KAI LIN
Outcome results
None listed