Post-Stroke Cognitive Impairment: Neurovascular Mechanisms and Non-Invasive Brain Stimulation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Montreal Cognitive Assessment (MoCA)
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 participants with post-stroke cognitive impairment (PSCI).
详细描述
The goal of this study is to learn important information about the effects of electrical stimulation (Transcranial direct current stimulation (tDCS) on brain functioning in those with post-stroke cognitive impairment (PSCI). The findings will help determine how stimulation affects the brain's activity, cerebral blood flow, and circulating blood biomarkers of neuroinflammation after stroke. The study will use different forms of non-invasive brain imaging to see whether stimulation changes how the brain responds during a memory task. Functional near-infrared spectroscopy (fNIRS) and electroencephalograph (EEG) will be used, we will also collect blood samples for the biomarkers of inflammation. 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ischemic stroke participants in sub-acute phase (at least 10 days after stroke event or discharge and under 5 months post-event) with cognitive dysfunction (MoCA <26);
排除标准
- •clinically significant or unstable medical or psychiatric condition;
- •diagnosis of severe depression;
- •history of relevant neurological diagnosis (e.g., epilepsy);
- •previous neurosurgical procedure with craniectomy;
- •contraindications to tDCS (implanted brain medical devices);
- •severe visual impairment, hearing impairment, aphasia, neglect or dementia.
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: Changes from baseline after intervention week (two weeks), one and three months
It is a 30-point test about several cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation) and a screening tool used of MCI and dementia.
NIH Toolbox
时间窗: Changes from baseline after one and three months
NIH Toolbox tests is a computarize test that acess fluid abilities (i.e., working memory, processing speed, episodic memory, and two aspects of executive functioning) and crystallized abilities (i.e., dependent upon past learning and experience), resulting in Standard Scores for these superordinate categories, as well as a total Composite score of all tests.These norms were previously reported to align with the age-corrected normative data for the traditional neuropsychological measures.
次要结局
- Neurovascular Coupling - Cerebral blood flow (fNIRS)(Changes on fNIRS signal from baseline after after intervention week (two weeks), one and three months)
- Brain Function (EEG)(Changes on EEG signal from baseline after after intervention week (two weeks), one and three months)
- Neurovascular Coupling - (DVA)(Changes on maximal arteriolar dilation and mean maximal venular dilation from baseline after intervention week (two weeks), one and three months)
- Blood markers(Changes on blood marker levels from baseline after intervention week (two weeks), one and three months)