Sleep as a Model to Understand and Manipulate Cortical Activity in Order to Promote Neuroplasticity and Functional Recovery After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change from baseline in visual exploration and sleep parameters and the effect of cTBS
研究概览
简要总结
Brain functions are supported by multiple cell types, including neuronal and non-neuronal cells that are connected into complex networks. When the connectivity between those cells is altered or disrupted, the functioning of the brain is impaired. In stroke, the interruption of blood supply to the neural circuits results in connectivity damage and permanent disabilities. Experimental evidence suggests that some types of brain state, including sleep, can protect brain tissue from stroke and "repair" the damaged circuits. This project will investigate the neuronal mechanism underlying the protective effect of sleep on brain connectivity and network activity. To this end, the investigators will use a collection of state-of-the-art technologies including high-density electroencephalography (hd-EEG), transcranial magnetic stimulation (TMS) and transcranial alternating current stimulation (tACS). Perspectives include a better understanding of the causes and consequences of the perturbed electrical activity of the brain during sleep in stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent as documented by signature
- •Age between 18 and 80 years
- •First-ever right-sided stroke
- •Normal or corrected to normal vision
- •Demonstration of left hemispatial neglect (after a right-hemispheric brain lesion) found in a comprehensive neuropsychological test battery and clinical assessment
- •At least 3 weeks post-stroke
排除标准
- •Concomitant neurodegenerative diseases
- •Psychiatric diseases
- •Decompressive craniectomy
- •History of documented sleep disorders in the medical record (e.g. insomnia, hypersomnia, rem-sleep behaviour disorder)
- •Epileptic seizures
- •Implanted medical devices (e.g.: pacemakers, cochlear implants, implanted neurostimulators)
- •Presence of metal in the region of the head (excluding fixed dental implants such as tooth fillings or fixed dental braces)
- •Medication with drugs possibly lowering the seizure threshold
- •Alcohol or drug abuse
- •Inability to follow the procedures of the study
- •For female patients: in order to participate in the study, female patients in reproductive age need to take a pregnancy test (a standard urine pregnancy test will be provided).
结局指标
主要结局
Change from baseline in visual exploration and sleep parameters and the effect of cTBS
时间窗: Day 3
Relationship of visual exploration (mean cumulative fixation duration) to sleep parameters (slow wave activity and spindles) from the baseline to post-cTBS sleep.
Change from baseline in the effect of tACS on visual exploration
时间窗: Day 2
Group comparison of visual exploration task (mean cumulative fixation duration) between real and sham tACS.
次要结局
- The effect of tACS on sleep(Day 1 to 2)
- The effect of cTBS on sleep(Day 1 to 3)