Ultrasonography of the Neuromuscular Degeneration Behavior in ALS: a Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Measuring echointensity of peripheral muscles using an ultrasound device
研究概览
简要总结
Amyotrophic Lateral Sclerosis (ALS) is a progressive and fatal neurological disease.
An exhaustive and frequent clinical evaluation can lead to establish an adequate and early treatment of the consequences of its evolution.
Objectives.
- To evaluate the evolution of diaphragmatic and peripheral neuromuscular degeneration by ultrasound examination in patients with ALS and to establish possible evolution patterns.
- To verify the relationship between the degenerative peripheral and diaphragmatic neuromuscular changes evaluated by ultrasonography and changes in clinical scales frequently used.
- To compare the ultrasonographic features of subjects with ALS and a sample of healthy subjects 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, with an interval of at least 3 months between tests. Bilateral and cross sectional ultrasonography of several peripheral muscles and diaphragm will be performed at rest and during muscle contraction. All the images will be processed and analyzed for obtaining morphometric variables (muscle thickness) and textural ones (echogenic variation, entropy, homogeneity, textural contrast and correlation). Frequency of twitches will be also recorded in peripheral muscles.Also clinical features will be noted, every time of the 3 exams, from Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-r), British Medical Council Research Scale(MRC), and routine pulmonary tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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 echointensity of peripheral muscles using an ultrasound device
时间窗: 3 months
These measurements will be carried out in the biceps brachialis, forearm flexors, thenar eminence muscle, quadriceps and tibialis anterior which will be compared between patient with ALS and control group.
Thickness Fraction of the Diaphragm in ALS patients and control group.
时间窗: 3 months
It is calculated as the difference between thickness at end inspiration and end expiration
Measuring thickness of peripheral muscles using an ultrasound device
时间窗: 3 months
These measurements will be carried out in the biceps brachialis, forearm flexors, thenar eminence muscle, quadriceps and tibialis anterior which will be compared between patient with ALS and control group.
Measuring sonoelastography of peripheral muscles using an ultrasound device
时间窗: 3 months
These measurements will be carried out in the biceps brachialis, forearm flexors, thenar eminence muscle, quadriceps and tibialis anterior which will be compared between patient with ALS and control group.
Diaphragmatic Excursion (quiet and forced) of the Diaphragm in ALS patients and control group
时间窗: 3 months
Displacement of the right diaphragm dome
次要结局
- Measurement of muscle fasciculations using an ultrasound device(3 months)
- Measurement of muscle strength using Medical Research Council Scale (MRCs)(3 months)
- Measurement Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-r)(3 months)
- Maximal Inspiratory Pressure (MIP)(3 months)
- Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)(3 months)
- Measuring Forced Vital Capacity(3 months)
- Sniff- nasal inspiratory pressure (SNIP)(3 months)
- Peak Cough Flow (PCF)(3 months)
- Cumulative time percentage with SpO2 under 90% (CT90)(3 months)
研究者
Antonio Tomás Ríos-Cortés
Msc Physiotherapist
Hospital General Universitario Santa Lucia