CI

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ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02507713
NCT02507713N/ACompleted

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

Universidad Católica San Antonio de Murcia·observational·Posted Jul 24, 2015·Updated Jul 24, 2015

In Brief

An observational study for Amyotrophic Lateral Sclerosis. Completed, enrolled 60 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 24, 2015
Enrollment StartSep 1, 2013
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.9 years ago