Multimodal Investigation of Neural Plasticity Induced by Non-invasive Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in glutamate concentration (fMRS)
研究概览
简要总结
This study will evaluate the effects of a form of non-invasive brain stimulation on brain functioning and memory in cognitively intact older adults (healthy controls, HC) and in those with mild cognitive impairment (MCI).
详细描述
The goal of this study is to learn important information about the effects of weak electrical stimulation (known as high-definition transcranial direct current stimulation or HD-tDCS) on brain functioning in those with mild cognitive impairment (MCI). The findings will help determine how stimulation affects brain's activity and metabolism (in particular, the neurotransmitter glutamate). Ultimately, this information may help develop new treatments for those with Alzheimer's disease. The study will use different forms of brain imaging to see whether stimulation changes how the brain responds during a memory task. Functional magnetic resonance spectroscopy (fMRS), functional magnetic resonance imaging (fMRI), and functional near-infrared spectroscopy (fNIRS) will be used. The study also uses cognitive tests and questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal cognition for HC and diagnosis of Mild Cognitive Impairment (MCI) for MCI participants
- •Right-handedness
- •Magnetic resonance compatible, criteria that also apply for high definition transcranial direct current stimulation (HD-tDCS; e.g., absence of metallic or electronic implants in the upper body or head)
排除标准
- •History of other contributing neurological or medical conditions known to affect cognitive functioning
- •Significant mental illness
- •Sensory impairments that limit ability to participate
- •History of alcohol or drug abuse/dependence
研究组 & 干预措施
MCI active tDCS
3 milliAmp dose of HD-tDCS treatment for 20 minutes, for 1 session.
干预措施: active tDCS (Device)
HC sham tDCS
Sham (placebo) dose of HD-tDCS treatment for 20 minutes, for 1 session.
干预措施: sham tDCS (Device)
HC active tDCS
3 milliAmp dose of HD-tDCS treatment for 20 minutes, for 1 session.
干预措施: active tDCS (Device)
MCI sham tDCS
Sham (placebo) dose of HD-tDCS treatment for 20 minutes, for 1 session.
干预措施: sham tDCS (Device)
结局指标
主要结局
Changes in glutamate concentration (fMRS)
时间窗: average on 1 week
Analyses via fMRS using units of concentration
Changes in brain activation (fMRI)
时间窗: average of 1 week
Analyses via fMRI using units of brain activation
次要结局
- Changes in memory performance(average of 1 week)
- Changes in brain activation (fNIRS)(immediate, concurrent with tDCS)
研究者
Alexandru Iordan
Assistant Professor of Psychiatry, Medical School
University of Michigan