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Ultrasonography of the Neuromuscular Degeneration Behavior in Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03683875
Recruitment Status : Completed
First Posted : September 25, 2018
Last Update Posted : November 5, 2021
Sponsor:
Collaborator:
Universidad de Murcia
Information provided by (Responsible Party):
Antonio Tomás Ríos-Cortés, Hospital General Universitario Santa Lucia

Study Description
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Brief Summary:

Amyotrophic Lateral Sclerosis (ALS) is a progressive and fatal neurological disease.

An exhaustive and frequent clinical evaluation can lead to establish an adequate and early treatment of the consequences of its evolution.

Objectives.

  1. To evaluate the evolution of diaphragmatic and peripheral neuromuscular degeneration by ultrasound examination in patients with ALS and to establish possible evolution patterns.
  2. To verify the relationship between the degenerative peripheral and diaphragmatic neuromuscular changes evaluated by ultrasonography and changes in clinical scales frequently used.
  3. To compare the ultrasonographic features of subjects with ALS and a sample of healthy subjects 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, with an interval of at least 3 months between tests. Bilateral and cross sectional ultrasonography of several peripheral muscles and diaphragm will be performed at rest and during muscle contraction. All the images will be processed and analyzed for obtaining morphometric variables (muscle thickness) and textural ones (echogenic variation, entropy, homogeneity, textural contrast and correlation). Frequency of twitches will be also recorded in peripheral muscles.Also clinical features will be noted, every time of the 3 exams, from Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-r), British Medical Council Research Scale(MRC), and routine pulmonary tests.

Condition or disease
Amyotrophic Lateral Sclerosis

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 26 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 9 Months
Official Title: Ultrasonography of the Neuromuscular Degeneration Behavior in ALS: a Longitudinal Study
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : March 10, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Measuring thickness of peripheral muscles using an ultrasound device [ Time Frame: 3 months ]
    These measurements will be carried out in the biceps brachialis, forearm flexors, thenar eminence muscle, quadriceps and tibialis anterior which will be compared between patient with ALS and control group.

  2. Measuring echointensity of peripheral muscles using an ultrasound device [ Time Frame: 3 months ]
    These measurements will be carried out in the biceps brachialis, forearm flexors, thenar eminence muscle, quadriceps and tibialis anterior which will be compared between patient with ALS and control group.

  3. Measuring sonoelastography of peripheral muscles using an ultrasound device [ Time Frame: 3 months ]
    These measurements will be carried out in the biceps brachialis, forearm flexors, thenar eminence muscle, quadriceps and tibialis anterior which will be compared between patient with ALS and control group.

  4. Thickness Fraction of the Diaphragm in ALS patients and control group. [ Time Frame: 3 months ]
    It is calculated as the difference between thickness at end inspiration and end expiration

  5. Diaphragmatic Excursion (quiet and forced) of the Diaphragm in ALS patients and control group [ Time Frame: 3 months ]
    Displacement of the right diaphragm dome


Secondary Outcome Measures :
  1. Measurement of muscle fasciculations using an ultrasound device [ Time Frame: 3 months ]
    Each peripheral muscle will be screened during 30 seconds

  2. Measurement of muscle strength using Medical Research Council Scale (MRCs) [ Time Frame: 3 months ]

    Graded on the medical research council scale. This scale grades muscle power on a scale of 0 to 5:

    Grade 0: no movement is observed Grade 1: only a trace or flicker of movement is seen or flet in the muscle. or fasciculation is observed Grade 2: movement is possible only if the resistance of gravity is removed Grade 3: movement against gravity is possible but not against resistance of the examiner Grade 4: muscle stregth is reduced but muscle contraction can move joint against gravity and resistance Grade 5: muscle contracts normally against full resistance


  3. Measurement Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-r) [ Time Frame: 3 months ]

    Questionnaire with 12 items with a score from 0 to 4 each item:

    1. Speech
    2. Salivation
    3. Swallowing
    4. Handwriting 5a. Cutting food and handling utensils (patients without gastrostomy) 5b. Cutting food and handling utensils(scale for patients with gastrostomy)

    6. Dressing and hygiene 7. Turning in bed and adjusting bed clothes 8. Walking 9. Climbing stairs 10. Dyspnea 11. Orthopnea 12. Respiratory insufficiency

    There are three main pathways of progression, the questions are also divided in relation to the types of onset. Questions 1 to 3 are related to bulbar onset, questions 4 to 9 are related to limb onset and questions 10-12 are related to respiratory onset. The Scale goes from 0 to 48, more points meaning better situation.


  4. Measuring Forced Vital Capacity [ Time Frame: 3 months ]
    This volume expressed in liters will be measured in supine and seated positions.

  5. Maximal Inspiratory Pressure (MIP) [ Time Frame: 3 months ]
    Measure of the strength of inspiratory muscles expressed in centimeters of water, is the highest mouth pressure sustained for 1 s during a maximum inspiratory effort

  6. Sniff- nasal inspiratory pressure (SNIP) [ Time Frame: 3 months ]
    It consists of measuring nasal pressure in an occluded nostril during a maximal sniff performed through the contralateral nostril, expressed in centimeters of water

  7. Peak Cough Flow (PCF) [ Time Frame: 3 months ]
    Maximal peak cough flow expressed in liters per minute

  8. Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2) [ Time Frame: 3 months ]
    Obtained by a radial arterial blood sample and expressed in millimeters of mercury

  9. Cumulative time percentage with SpO2 under 90% (CT90) [ Time Frame: 3 months ]
    SpO2 is an estimate of arterial oxygen saturation expressed in percentage under 90% obtained from a nocturnal oximetry


Eligibility Criteria
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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
Contacts and Locations
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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): NCT03683875


Locations
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Spain
Hospital General Universitario Santa Lucia
Cartagena, Murcia, Spain, 30202
Sponsors and Collaborators
Hospital General Universitario Santa Lucia
Universidad de Murcia
Investigators
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Principal Investigator: Antonio Tomás Ríos Cortés HOSPITAL GENERAL UNIVERSITARIO SANTA LUCIA - SERVICIO MURCIANO DE SALUD
More Information
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Additional Information:

Publications:

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Responsible Party: Antonio Tomás Ríos-Cortés, Msc Physiotherapist, Hospital General Universitario Santa Lucia
ClinicalTrials.gov Identifier: NCT03683875    
Other Study ID Numbers: ECO-ELA
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: November 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases