Ultrasonography of the Neuromuscular Degeneration Behavior in Amyotrophic Lateral Sclerosis

October 28, 2021 updated by: Antonio Tomás Ríos-Cortés, Hospital General Universitario Santa Lucia

Ultrasonography of the Neuromuscular Degeneration Behavior in ALS: a Longitudinal Study

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Murcia
      • Cartagena, Murcia, Spain, 30202
        • Hospital General Universitario Santa Lucia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with Amyotrophic Lateral Sclerosis

Description

Inclusion Criteria:

  • Definite ALS

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of muscle fasciculations using an ultrasound device
Time Frame: 3 months
Each peripheral muscle will be screened during 30 seconds
3 months
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 months
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.
3 months
Measuring Forced Vital Capacity
Time Frame: 3 months
This volume expressed in liters will be measured in supine and seated positions.
3 months
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
3 months
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
3 months
Peak Cough Flow (PCF)
Time Frame: 3 months
Maximal peak cough flow expressed in liters per minute
3 months
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
3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Santa Lucia

Collaborators

Universidad de Murcia

Investigators

  • Principal Investigator: Antonio Tomás Ríos Cortés, HOSPITAL GENERAL UNIVERSITARIO SANTA LUCIA - SERVICIO MURCIANO DE SALUD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

March 10, 2020

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 23, 2018

First Posted (Actual)

September 25, 2018

Study Record Updates

Last Update Posted (Actual)

November 5, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECO-ELA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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