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Completed

NCT Number: NCT02507713

Quantitative Neuromuscular Ultrasonography in Amyotrophic Lateral Sclerosis (ALS)

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad Católica San Antonio de Murcia

Guadalupe, Murcia, 30107, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Definite ALS.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

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

Acronym: ALS

Important dates

Study start
2013
Primary completion
2014
First posted
Jul 24, 2015
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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