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CompletedNCT02507713ALSUpdated Jul 24, 2015

Quantitative Neuromuscular Ultrasonography in Amyotrophic Lateral Sclerosis (ALS)

An observational study in Amyotrophic Lateral Sclerosis, sponsored by Universidad Católica San Antonio de Murcia. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-24.

Sponsored by Universidad Católica San Antonio de Murcia · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Amyotrophic Lateral Sclerosis

Keywords

  • Amyotrophic lateral sclerosis
  • Ultrasonography
  • Motor neurons
  • Neuromuscular diseases
  • Fasciculation
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In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's enrollment of 60 is below the median of 109 across 217 observational studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

Universidad Católica San Antonio de Murcia is the lead sponsor of 132 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patient with Amyotrophic Lateral Sclerosis.

Inclusion criteria

  • Definite ALS.

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Retrospective
Enrollment
60 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Measuring muscle thickness.

    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.

    Time frame: 6 months

Secondary outcomes

  1. Measurement muscle strength.

    Graded on the medical research council scale

    Time frame: 6 months

  2. Measurement ALS Functional Rating Scale (ALSFRS-r) scale.

    Recorded as the global score

    Time frame: 6 months

  3. Measurement muscle fasciculations.

    Each muscle will be screened during 10 s.

    Time frame: 6 months

  4. Measuring muscle echointensity.

    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.

    Time frame: 6 months

  5. Measuring nerve area.

    This measurement is carried out in the median and tibialis posterior nerves, which will be compared between patient with ALS and control group.

    Time frame: 6 months

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Study locations

1 site
  • Universidad Católica San Antonio de Murcia
    Guadalupe, Murcia 30107, Spain
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References and documents

Publications

  • Cartwright MS, Walker FO, Griffin LP, Caress JB. Peripheral nerve and muscle ultrasound in amyotrophic lateral sclerosis. Muscle Nerve. 2011 Sep;44(3):346-51. doi: 10.1002/mus.22035. Epub 2011 Aug 3. PubMed 21815172 ↗
  • Schreiber S, Abdulla S, Debska-Vielhaber G, Machts J, Dannhardt-Stieger V, Feistner H, Oldag A, Goertler M, Petri S, Kollewe K, Kropf S, Schreiber F, Heinze HJ, Dengler R, Nestor PJ, Vielhaber S. Peripheral nerve ultrasound in amyotrophic lateral sclerosis phenotypes. Muscle Nerve. 2015 May;51(5):669-75. doi: 10.1002/mus.24431. Epub 2015 Mar 14. PubMed 25155020 ↗
  • Arts IM, Pillen S, Schelhaas HJ, Overeem S, Zwarts MJ. Normal values for quantitative muscle ultrasonography in adults. Muscle Nerve. 2010 Jan;41(1):32-41. doi: 10.1002/mus.21458. PubMed 19722256 ↗
  • Mayans D, Cartwright MS, Walker FO. Neuromuscular ultrasonography: quantifying muscle and nerve measurements. Phys Med Rehabil Clin N Am. 2012 Feb;23(1):133-48, xii. doi: 10.1016/j.pmr.2011.11.009. Epub 2011 Dec 9. PubMed 22239880 ↗
  • Arts IMP, Overeem S, Pillen S, Jurgen Schelhaas H, Zwarts MJ. Muscle changes in amyotrophic lateral sclerosis: a longitudinal ultrasonography study. Clin Neurophysiol. 2011 Mar;122(3):623-628. doi: 10.1016/j.clinph.2010.07.023. PubMed 20810308 ↗
  • Arts IM, Overeem S, Pillen S, Kleine BU, Boekestein WA, Zwarts MJ, Jurgen Schelhaas H. Muscle ultrasonography: a diagnostic tool for amyotrophic lateral sclerosis. Clin Neurophysiol. 2012 Aug;123(8):1662-7. doi: 10.1016/j.clinph.2011.11.262. Epub 2012 Jan 13. PubMed 22244867 ↗
  • Arts IM, Overeem S, Pillen S, Schelhaas HJ, Zwarts MJ. Muscle ultrasonography to predict survival in amyotrophic lateral sclerosis. J Neurol Neurosurg Psychiatry. 2011 May;82(5):552-4. doi: 10.1136/jnnp.2009.200519. Epub 2010 Apr 14. PubMed 20392981 ↗
  • Pillen S, Arts IM, Zwarts MJ. Muscle ultrasound in neuromuscular disorders. Muscle Nerve. 2008 Jun;37(6):679-93. doi: 10.1002/mus.21015. PubMed 18506712 ↗
  • Arts IM, van Rooij FG, Overeem S, Pillen S, Janssen HM, Schelhaas HJ, Zwarts MJ. Quantitative muscle ultrasonography in amyotrophic lateral sclerosis. Ultrasound Med Biol. 2008 Mar;34(3):354-61. doi: 10.1016/j.ultrasmedbio.2007.08.013. Epub 2007 Oct 26. PubMed 17964067 ↗
  • Gdynia HJ, Muller HP, Ludolph AC, Koninger H, Huber R. Quantitative muscle ultrasound in neuromuscular disorders using the parameters 'intensity', 'entropy', and 'fractal dimension'. Eur J Neurol. 2009 Oct;16(10):1151-8. doi: 10.1111/j.1468-1331.2009.02663.x. Epub 2009 May 22. PubMed 19486136 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02507713
Lead sponsor
Universidad Católica San Antonio de Murcia
Responsible party
Jacinto Martínez-Payá (Professor of Human Anatomy and Biomedical Imaging, Universidad Católica San Antonio de Murcia) — Principal investigator
First posted
Jul 24, 2015
Start date
Sep 2013
Primary completion
Apr 2014
Last update
Jul 24, 2015

Study contacts

María E del Baño-Aledo, PhD
principal investigator · Human Anatomy Department. Universidad Católica San Antonio, Campus de los Jerónimos 138. 30107 Guadalupe, Murcia, Spain
View the source record on ClinicalTrials.gov ↗

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