Quantitative Neuromuscular Ultrasonography in Amyotrophic Lateral Sclerosis (ALS)

NCT02507713 | Completed

• 1 other identifier: PMAFI10/14
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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. 1.To establish the diagnostic value of ultrasonography in ALS.
2. 2.To evaluate the rate of muscle and nerve degeneration by ultrasonography in patients with ALS.
3. 3.To check the relationship between ultrasound, clinical variables and functional tests in patients with ALS.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

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

Outcome Measures

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.

  6 months

Secondary Outcomes (5)

• Measurement muscle strength.

  6 months

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

  6 months

• Measurement muscle fasciculations.

  6 months

• Measuring muscle echointensity.

  6 months

• Measuring nerve area.

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with Amyotrophic Lateral Sclerosis.

You may qualify if:

• Definite ALS.

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead

Study Sites (1)

Universidad Católica San Antonio de Murcia

Guadalupe, Murcia, 30107, Spain

Location

Related Publications (10)

• 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.

  PMID: 21815172 BACKGROUND

• 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.

  PMID: 25155020 BACKGROUND

• 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.

  PMID: 19722256 BACKGROUND

• 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.

  PMID: 22239880 RESULT

• 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.

  PMID: 20810308 RESULT

• 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.

  PMID: 22244867 RESULT

• 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.

  PMID: 20392981 RESULT

• Pillen S, Arts IM, Zwarts MJ. Muscle ultrasound in neuromuscular disorders. Muscle Nerve. 2008 Jun;37(6):679-93. doi: 10.1002/mus.21015.

  PMID: 18506712 RESULT

• 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.

  PMID: 17964067 RESULT

• 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.

  PMID: 19486136 RESULT

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Neuromuscular Diseases; Fasciculation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• María E del Baño-Aledo, PhD

  Human Anatomy Department. Universidad Católica San Antonio, Campus de los Jerónimos 138. 30107 Guadalupe, Murcia, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Human Anatomy and Biomedical Imaging

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 24, 2015
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

ES (1)