Brain Connectivity Measured With High-density Electroencephalography: a Novel Neurodiagnostic Tool for Stroke
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Magnetic Resonance Imaging measurement (work package 1, 2, and 3)
研究概览
简要总结
Emerging scientific results show that disrupted functional connectivity in stroke can explain behavioral impairments and predict their recovery over time. However, no technique is yet available for widespread use in clinics to examine how neural synchronization in brain networks is altered in stroke patients. This is crucial to determine favorable prognostic factors and to define individualized rehabilitation protocols. Importantly, the investigators have successfully used high-density electroencephalography (hdEEG) in healthy individuals to measure neural synchronization in brain networks. In this project, the investigators will develop methods and tools based on hdEEG for assessing functional connectivity in stroke patients. These methods and tools will be employed to examine how neural changes occurring after brain lesions explain behavioral impairments. The project will open the way for the use of hdEEG at the patient's bedside, as a neurodiagnostic tool for stroke as well as other brain disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In this study 125 stroke patients and 45 healthy participants will be recruited at the Institute for Research and Healthcare with a Scientific Character (IRCCS) San Camillo hospital.
- •Inclusion Criteria (patients):
- •right or left hemisphere damage
- •unilateral stroke
- •compliance with magnetic resonance imaging (e.g., no claustrophobia)
- •Inclusion Criteria (healthy participants):
- •compliance with magnetic resonance imaging (e.g., no claustrophobia)
排除标准
- •(both patients and healthy participants):
- •no comorbidities with psychiatric disorders
研究组 & 干预措施
stroke patients
Resting-state networks obtained through electroencephalography will be analyzed in a group of stroke patients.
干预措施: Connectivity measures (Device)
healthy participants
Resting-state networks obtained through electroencephalography will be analyzed in a group of healthy participants.
干预措施: Connectivity measures (Device)
结局指标
主要结局
Magnetic Resonance Imaging measurement (work package 1, 2, and 3)
时间窗: 6 months after the recruiting
Magnetic Resonance Imaging will be conducted using a 3 Tesla scanner. Specifically, T1-weighted Magnetic Resonance Imaging measure will be collected
High-density electroencephalography measurements (work package 1, 2, and 3)
时间窗: 6 months after the recruiting
High-density electroencephalography measurements, specifically focusing on resting state networks, will be performed using either a 128-channel or a 256-channel system
次要结局
- Funtional skills measurement (work package 3).(6 months after the recruiting)
- Cognitive performance measurements (work package 3)(6 months after the recruiting)
- Spasticity measurement (work package 3)(6 months after the recruiting)
- Muscle strength measurement (work package 3)(6 months after the recruiting)
- Sensorimotor impairment measurement (work package 3)(6 months after the recruiting)
- Activities of daily living measurement (work package 3)(6 months after the recruiting)
- Pain measurement (work package 3)(6 months after the recruiting)