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Amyotrophic Lateral SclerosisALSNCT02507713

Quantitative Neuromuscular Ultrasonography in Amyotrophic Lateral Sclerosis (ALS)

An observational study of Amyotrophic Lateral Sclerosis, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Amyotrophic Lateral Sclerosis
How many people
60 participants
Where
1 siteSpain
Study dates
Sep 2013to Apr 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patient with Amyotrophic Lateral Sclerosis.

Who may be able to join

  • Definite ALS.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Universidad Católica San Antonio de Murcia

    Guadalupe, Murcia, 30107

Other trials in Spain

About this study

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

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.

Read more
  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.

Keywords
Amyotrophic lateral sclerosis, Ultrasonography, Motor neurons, Neuromuscular diseases, Fasciculation
Medical subject headings
Amyotrophic Lateral Sclerosis, Neuromuscular Diseases, Fasciculation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (5)

  1. Measurement muscle strength.

    Graded on the medical research council scale

    Measured: 6 months

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

    Recorded as the global score

    Measured: 6 months

  3. Measurement muscle fasciculations.

    Each muscle will be screened during 10 s.

    Measured: 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.

    Measured: 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2015 (estimated)
  2. Study startSep 2013
  3. Primary completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02507713
Sponsor's protocol ID
PMAFI10/14
Acronym
ALS
Status last verified
Jul 2015
First submitted
20 Jul 2015
Last updated
24 Jul 2015
Results posted
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Amyotrophic Lateral Sclerosis, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measuring muscle thickness. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02507713, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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