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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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).)
- 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.)
研究者
Yu-Kai Lin
Tri-Service General Hospital
National Defense Medical Center, Taiwan