Ultrasound Markers for the Diagnosis, Disease Progression and Prognosis of Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Measuring muscle thickness.
研究概览
简要总结
Amyotrophic Lateral Sclerosis (ALS) is a progressive and fatal neurological disease. Nonspecific symptoms lead to a delay in the diagnosis, only confirmed by the electrophysiologic study.
Objectives.
- To establish the diagnostic value of ultrasonography in ALS.
- To evaluate the rate of muscle and nerve degeneration by ultrasonography in patients with ALS.
- To check the relationship between ultrasound, clinical variables and functional tests in patients with ALS.
Methods. A longitudinal observational study in a consecutive sample of patients diagnosed with ALS will be realized. All the patients will be examined 3 times during 6 months and capabilities associated with ALS and muscle strength will be assessed. Bilateral and cross sectional ultrasonography of several muscles and also median and tibial nerves will be performed. All the images will be processed and analyzed for obtaining morphometric variables (muscle thickness and nerve area) and textural ones (echogenic variation, entropy, homogeneity, textural contrast and correlation). Frequency of twitches will be also recorded. After longitudinal study, a survival study will be performed in relation to functional and sonographic variables.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Definite ALS.
排除标准
- •Primary Lateral Sclerosis (PLS)
- •Other forms of motor neuron disorders.
结局指标
主要结局
Measuring muscle thickness.
时间窗: 6 months
This measurement is carried out in the biceps brachialis, forearm flexors, quadriceps and tibialis anterior, which will be compared between patient with ALS and control group.
次要结局
- Measurement ALS Functional Rating Scale (ALSFRS-r) scale.(6 months)
- Measurement muscle fasciculations.(6 months)
- Measurement muscle strength.(6 months)
- Measuring muscle echointensity.(6 months)
- Measuring nerve area.(6 months)
研究者
Jacinto Martínez-Payá
Professor of Human Anatomy and Biomedical Imaging
Universidad Católica San Antonio de Murcia
