Clinical trial NCT02507713: Quantitative Neuromuscular Ultrasonography in Amyotrophic Lateral Sclerosis (ALS)
Official title: Ultrasound Markers for the Diagnosis, Disease Progression and Prognosis of Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic lateral sclerosis
Ultrasonography
Motor neurons
Neuromuscular diseases
Fasciculation
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Amyotrophic Lateral Sclerosis.

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.


Eligibility criteria: Inclusion Criteria:

* Definite ALS.

Exclusion Criteria:

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

Primary outcomes:
measure: Measuring muscle thickness.
timeFrame: 6 months
Secondary outcomes:
measure: Measurement muscle strength.
timeFrame: 6 months
measure: Measurement ALS Functional Rating Scale (ALSFRS-r) scale.
timeFrame: 6 months
measure: Measurement muscle fasciculations.
timeFrame: 6 months
measure: Measuring muscle echointensity.
timeFrame: 6 months
measure: Measuring nerve area.
timeFrame: 6 months
Other outcomes:
Locations:
city: Guadalupe
country: Spain
facility: Universidad Católica San Antonio de Murcia
state: Murcia
Study officials:
affiliation: Human Anatomy Department. Universidad Católica San Antonio, Campus de los Jerónimos 138. 30107 Guadalupe, Murcia, Spain
name: María E del Baño-Aledo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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