Quantitative Neuromuscular Ultrasonography in Amyotrophic Lateral Sclerosis (ALS)

Completed

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT02507713
• Lead Sponsor: Universidad Católica San Antonio de Murcia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2014-04
• Status Verified: 2015-07
• Study First Submitted: 2015-07-20
• Study First Submitted QC: 2015-07-23
• Last Update Submitted: 2015-07-23
• Study First Posted: 2015-07-24
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Definite ALS.

Exclusion Criteria

• Primary Lateral Sclerosis (PLS)
• Other forms of motor neuron disorders.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measuring muscle thickness.	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.

Secondary Outcome Measures

Name	Time	Method
Measurement ALS Functional Rating Scale (ALSFRS-r) scale.	6 months	Recorded as the global score
Measurement muscle fasciculations.	6 months	Each muscle will be screened during 10 s.
Measurement muscle strength.	6 months	Graded on the medical research council scale
Measuring muscle echointensity.	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.	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.

Trial Locations

Locations (1)

Universidad Católica San Antonio de Murcia; 🇪🇸 Guadalupe, Murcia, Spain