TMS in Preclinical and Prodromal AD: Modulation of Brain Networks and Memory
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Paired Associative Face Name Memory Test
研究概览
简要总结
The purpose of this study is to assess the effects of non-invasive brain stimulation on memory in cognitively unimpaired older adults and in patients amnestic mild cognitive impairment (aMCI) due to Alzheimer's disease (AD). This study will use repetitive Transcranial Magnetic Stimulation (rTMS) to stimulate nodes of the Default Mode Network (DMN)- which is thought to support episodic memory and to be affected by Alzheimer's pathology.
We will use functional connectivity MRI (fcMRI) to assess changes in functional network architecture following the stimulation. We will also assess putative cognitive improvements resulting from the stimulation by in-depth memory testing.
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)
盲法说明
All participants will undergo SHAM stimulation as a control condition. They will be blinded as to whether they are receiving active or SHAM stimulation.
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between the ages of 60-85
- •All participants will be native English speakers
- •Willing and able to consent to the protocol and undergo imaging and neuropsychological testing at the specified time points
- •Participants with aMCI will be asked to bring a study partner to all visits
- •Only patients with very mild or mild cognitive impairment (CDR 0.5 or CDR 1) will be included in the prodromal AD cohort
排除标准
- •History of head trauma involving loss of consciousness or alteration in consciousness
- •Another major neurologic or psychiatric condition
- •Known presence of a structural brain lesion (e.g. tumor, cortical infarct)
- •Any contraindication to MRI, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body
- •Longstanding premorbid history (i.e. longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed
- •Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol.
- •Unwilling to return for follow-up, undergo neuropsychological testing, TMS, and MR imaging
结局指标
主要结局
Paired Associative Face Name Memory Test
时间窗: up to 5 weeks
A test of memory for face-name associations
次要结局
- Changes in intrinsic functional connectivity(up to 5 weeks)
研究者
Bradford Clark Dickerson, M.D.
Associate Neurologist
Massachusetts General Hospital