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临床试验/NCT02507713
NCT02507713已完成不适用

Ultrasound Markers for the Diagnosis, Disease Progression and Prognosis of Amyotrophic Lateral Sclerosis

Universidad Católica San Antonio de Murcia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年9月最近更新:
适应症

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.

  1. To establish the diagnostic value of ultrasonography in ALS.
  2. To evaluate the rate of muscle and nerve degeneration by ultrasonography in patients with ALS.
  3. 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

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

发起方
Universidad Católica San Antonio de Murcia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacinto Martínez-Payá

Professor of Human Anatomy and Biomedical Imaging

Universidad Católica San Antonio de Murcia

研究点 (1)

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