Quantitative Neuromuscular Ultrasonography in Amyotrophic Lateral Sclerosis (ALS) (ALS)
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|ClinicalTrials.gov Identifier: NCT02507713|
Recruitment Status : Completed
First Posted : July 24, 2015
Last Update Posted : July 24, 2015
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.
- 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.
|Condition or disease|
|Amyotrophic Lateral Sclerosis|
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Observational Model:||Case Control|
|Official Title:||Ultrasound Markers for the Diagnosis, Disease Progression and Prognosis of Amyotrophic Lateral Sclerosis|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||April 2014|
- Measuring muscle thickness. [ Time Frame: 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.
- Measurement muscle strength. [ Time Frame: 6 months ]Graded on the medical research council scale
- Measurement ALS Functional Rating Scale (ALSFRS-r) scale. [ Time Frame: 6 months ]Recorded as the global score
- Measurement muscle fasciculations. [ Time Frame: 6 months ]Each muscle will be screened during 10 s.
- Measuring muscle echointensity. [ Time Frame: 6 months ]It will be measured using the Image J (v.1.48) software in the biceps brachialis, forearm flexors, quadriceps and tibialis anterior, which will be compared between patient with ALS and control group.
- Measuring nerve area. [ Time Frame: 6 months ]This measurement is carried out in the median and tibialis posterior nerves, which will be compared between patient with ALS and control group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507713
|Universidad Católica San Antonio de Murcia|
|Guadalupe, Murcia, Spain, 30107|
|Principal Investigator:||María E del Baño-Aledo, PhD||Human Anatomy Department. Universidad Católica San Antonio, Campus de los Jerónimos 138. 30107 Guadalupe, Murcia, Spain|