Biomarker-based Prediction of Cognitive Effects and Potential Mechanisms of Theta-burst Stimulation (TBS) in Subjects With Mild Cognitive Impairment (MCI)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 50-90 year
- •Subjects meet Petersen's criteria for mild cognitive impairment (Petersen, Smith et al. 1999)
- •The CDR of MCI patients can be 0-0.5
- •Amyloid PET should ever be performed
排除标准
- •Any subject has a definite diagnosis of epilepsy or history of seizure attack.
- •Current or past history of clinically significant neurological insults affecting brain structure or function like completed stroke, head injury or brain tumor.
- •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.
- •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.
- •Any females who is pregnant or lactating.
- •General MRI, TMS and/or PET exclusion criteria including subjects who had received brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or other metal devices/ objects that are not MR compatible in the body.
- •Withdrawal criteria
- •Complications onset after intervention that affect efficacy and safety judgments.
- •New onset or progression of disease that may affect outcomes.
- •Use of other therapies or drugs during the intervention period to change cognitive functions.
- •Any subjects who are recognized as high risk of adverse effects by principle investigator.
结局指标
主要结局
Montreal Cognitive Assessment
时间窗: 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
Mini-Mental State Examination ( MMSE )
时间窗: 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
次要结局
- The standard uptake values changes of FDG-PET(Before and immediately after TBS intervention)