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Quantitative Neuromuscular Ultrasonography in Amyotrophic Lateral Sclerosis (ALS) (ALS)

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ClinicalTrials.gov Identifier: NCT02507713
Recruitment Status : Completed
First Posted : July 24, 2015
Last Update Posted : July 24, 2015
Sponsor:
Information provided by (Responsible Party):
Jacinto Martínez-Payá, Universidad Católica San Antonio de Murcia

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.


Condition or disease
Amyotrophic Lateral Sclerosis

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Ultrasound Markers for the Diagnosis, Disease Progression and Prognosis of Amyotrophic Lateral Sclerosis
Study Start Date : September 2013
Actual Primary Completion Date : April 2014





Primary Outcome Measures :
  1. Measuring muscle thickness. [ Time Frame: 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 Outcome Measures :
  1. Measurement muscle strength. [ Time Frame: 6 months ]
    Graded on the medical research council scale

  2. Measurement ALS Functional Rating Scale (ALSFRS-r) scale. [ Time Frame: 6 months ]
    Recorded as the global score

  3. Measurement muscle fasciculations. [ Time Frame: 6 months ]
    Each muscle will be screened during 10 s.

  4. Measuring muscle echointensity. [ Time Frame: 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.

  5. Measuring nerve area. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patient with Amyotrophic Lateral Sclerosis.
Criteria

Inclusion Criteria:

  • Definite ALS.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507713


Locations
Spain
Universidad Católica San Antonio de Murcia
Guadalupe, Murcia, Spain, 30107
Sponsors and Collaborators
Universidad Católica San Antonio de Murcia
Investigators
Principal Investigator: María E del Baño-Aledo, PhD Human Anatomy Department. Universidad Católica San Antonio, Campus de los Jerónimos 138. 30107 Guadalupe, Murcia, Spain

Publications of Results:

Other Publications:
Responsible Party: Jacinto Martínez-Payá, Professor of Human Anatomy and Biomedical Imaging, Universidad Católica San Antonio de Murcia
ClinicalTrials.gov Identifier: NCT02507713     History of Changes
Other Study ID Numbers: PMAFI10/14
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015

Keywords provided by Jacinto Martínez-Payá, Universidad Católica San Antonio de Murcia:
Amyotrophic lateral sclerosis
Ultrasonography
Motor neurons
Neuromuscular diseases
Fasciculation

Additional relevant MeSH terms:
Sclerosis
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases