Investigating the Impact of Transcranial Magnetic Stimulation (TMS) on Amyloid and Tau Clearance Via Glymphatic Function in Prodromal Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- NIH Toolbox
研究概览
简要总结
The purpose of this study is to use transcranial magnetic stimulation (TMS) in older adults to impact the glymphatic system. The glymphatic system is a brain-wide clearance pathway that plays a crucial role in removing dysfunctional proteins in Alzheimer's disease. This project aims to investigate if TMS can help glymphatic function and reduce levels of these proteins in those with mild cognitive impairment.
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
- Double (Participant, Outcomes Assessor)
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
- •Individuals with mild cognitive impairment (MCI Group)
- •Inclusion Criteria:
- •Age 18-85 years
- •MCI subjective criteria: self- or informant-reported cognitive complaint
- •Objective cognitive impairment supported by one of the following measures of general cognitive function: (a) classified as MCI via the NACC-UDS 3.0 neuropsychological battery using the typical neuropsychological criteria for MCI diagnosis (1 score on any test at least1.5 SD below the mean); or (b) classified as MCI via the NACC-UDS 3.0 neuropsychological battery using the Jak/Bondi neuropsychological criteria for MCI diagnosis(2 scores at least 1 SD below the mean in one domain, or 3 scores at least 1SD below the mean across domains)
- •Right-handed
- •English speaking
- •Able to attend daily intervention and outcome measurements for ~15 days over a 6 month period.
- •Not enrolled in another interventional study within 6 months prior to beginning this study
排除标准
- •Contraindications to transcranial magnetic stimulation (TMS) or magnetic resonance imaging (MRI)
- •Reported sudden or steep decline of cognitive performance
- •Telephone Interview for cognitive impairment (TICS) score
- •Other neurological disorders (e.g., stroke, head injuries, or multiple sclerosis)
- •Psychiatric disorder (except stable late-life depression due to its high prevalence in MCI individuals)
- •Current cancer treatment or other comorbid/unstable medical conditions that might independently affect cognitive function
结局指标
主要结局
NIH Toolbox
时间窗: Day 1(baseline for block 1), Day 14(post block 1), Day 70 (Baseline block 2), Day 84 (post block 2)
The NIH Toolbox Cognition Battery, recommended for ages 7+, consists of tests of multiple constructs. It yields individual test scores and the following summary scores: Total Cognition Composite, Fluid Composite (includes Dimensional Change Card Sort, Flanker Inhibitory Control and Attention, Picture Sequence Memory (Form A), List Sorting Working Memory, and Pattern Comparison tests), and Crystallized Composite (includes Picture Vocabulary and Oral Reading Recognition tests).
次要结局
未报告次要终点
研究者
Ying-hui Chou
Principle Investigator
University of Arizona