Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance Myography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Skulpt, Inc.
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Muscle health as captured by EIM measurements
研究概览
简要总结
The purpose of this protocol is to test a new Electrical Impedance Myography (EIM) device and study its reliability and ability to differentiate ALS patients from healthy controls.
详细描述
Investigators will study 10 ALS patients and at least 10 age-matched healthy controls between the ages of 21 and 85 years old. For all subjects, EIM measurements will be performed on four muscles: two in the upper and two in the lower extremities, using 8 different EIM sensors. Measurements will be repeated one time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of probable or definite ALS by the El Escorial Criteria
排除标准
- •History of superimposed generalized neuromuscular disease
- •Primary lateral sclerosis or other atypical motor neuron disorders
- •Forced vital capacity of less than 50%
- •Presence of disease for greater than 5 years since symptom onset
结局指标
主要结局
Muscle health as captured by EIM measurements
时间窗: One time visit - Day 1
EIM measurements will be performed with several electrode arrays at one visit per patient. The data captured from ALS and healthy subjects will be used to refine and finalize electrode array design development for the EIM system.
次要结局
未报告次要终点