Quantitative Neuromuscular Ultrasonography in Amyotrophic Lateral Sclerosis (ALS)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02507713

Acronym

ALS

Enrollment

Registered

2015-07-24

Start date

2013-09-30

Completion date

Unknown

Last updated

2015-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic lateral sclerosis, Ultrasonography, Motor neurons, Neuromuscular diseases, Fasciculation

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Definite ALS.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Measurement muscle strength.	6 months	Graded on the medical research council scale
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.
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.

Countries

Spain

Outcome results