Evaluation and Characterization of Infraclinical Sensory Deficits in Amyotrophic Lateral Sclerosis by Brain Imaging and Electrophysiology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Brain activity
研究概览
简要总结
The main objective is to determine the origin of somatosensory alteration in patients with ALS and to evaluate its impact on brain activity by coupling different imaging modalities and indirect electrophysiology.
The secondary objective is to evaluate whether the observed functional changes in MEG / EEG and functional MRI correlate with structural lesions revealed with diffusion MRI (anatomo-functional connectivity of the brain).
详细描述
Somatosensory evoked potentials (SEPs) produced by ulnar nerve electrical stimulation will be collected with combined MEG and EGG.
Functional MRI will be performed during electrical stimulation of ulnar nerve and during mechanical vibration of ADM tendon.
Brain diffusion MRI will be performed. Anatomical MRI will be done for source location. Brain resting state activity will be recorded with MEG/EEG and fMRI.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ALS, MRC score ≥ 4 at least in one hand
- •Controls: no history of neurological disorders, right-handed
排除标准
- •contraindication to MRI
研究组 & 干预措施
functional MRI
a group of patients with ALS and a group of gender and age matched healthy subjects will have functional MRI acquisition conditioned by electrical and mechanical stimuli of ADM proprioceptors
干预措施: functional MRI (Device)
structural MRI
a group of patients with ALS and a group of gender and age matched healthy subjects will have diffusion MRI acquisition to evaluate their brain structures
干预措施: structural MRI (Device)
EEG/MEG
a group of patients with ALS and a group of gender and age matched healthy subjects will have functional MRI acquisition conditioned by electrical stimuli of ADM proprioceptors
干预措施: EEG/MEG (Device)
结局指标
主要结局
Brain activity
时间窗: 1 hour
Brain parametric maps
次要结局
- Brain connectivity(15 min)