Study of Structural and Functional Brain Connectivity Changes in ALS (CoALS-II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- fMRI
研究概览
简要总结
This study will try to understand the difference in brain structure between ALS patients and healthy people of similar age. ALS is a condition affecting the nervous system with disruption of the brain networks. This study aims to understand these disruptions and determine their significance in ALS.
详细描述
Participants and healthy controls will be consented into the study. After consent, details including age, duration of disease, ALSFRS score, and grip strength will be collected. Participants will be trained to perform a grip and release task using a foam ball for 1 minute while inside an MRI scanner. Anatomical, functional and diffusion MRI sequences will be acquired during the scanning, and total scan time will be approximately 1 hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Based on El Escorial Criteria we will select Probable or Definite ALS.
- •Healthy controls age matched to ALS patients
- •Subjects should be able to lie down in a scanner and undergo an hour-long MRI study
- •Subjects should be able to understand instructions, provide consent and perform a hand task while inside the scanner
排除标准
- •Unable to undergo MRI due to any reason
- •ALS patients having high aspiration risk
- •Patients having cognitive limitations which prevents them from understanding the study requirements, providing consent or perform tasks inside the scanner.
研究组 & 干预措施
ALS patients
Patients with ALS
干预措施: fMRI (Other)
Healthy controls
Age-matched healthy controls
干预措施: fMRI (Other)
结局指标
主要结局
fMRI
时间窗: 1 hour
Brain network generation and analysis will be performed for anatomical and functional imaging
次要结局
未报告次要终点