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Amyotrophic Lateral SclerosisNCT03683875

Ultrasonography of the Neuromuscular Degeneration Behavior in Amyotrophic Lateral Sclerosis

An observational study of Amyotrophic Lateral Sclerosis, run by Hospital General Universitario Santa Lucia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Amyotrophic Lateral Sclerosis
How many people
26 participants
Where
1 siteSpain
Study dates
1 Oct 2018to 10 Mar 2020
How long will I take part?
9 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patient with Amyotrophic Lateral Sclerosis

Who may be able to join

  • Definite ALS

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital General Universitario Santa Lucia

    Cartagena, Murcia, 30202

Other trials in Spain

About this study

Official title: 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.

Read more

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.
Medical subject headings
Amyotrophic Lateral Sclerosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measuring thickness of peripheral muscles using an ultrasound device

    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.

    Measured: 3 months

  2. Measuring echointensity of peripheral muscles using an ultrasound device

    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.

    Measured: 3 months

  3. Measuring sonoelastography of peripheral muscles using an ultrasound device

    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.

    Measured: 3 months

  4. Thickness Fraction of the Diaphragm in ALS patients and control group.

    It is calculated as the difference between thickness at end inspiration and end expiration

    Measured: 3 months

  5. Diaphragmatic Excursion (quiet and forced) of the Diaphragm in ALS patients and control group

    Displacement of the right diaphragm dome

    Measured: 3 months

Secondary outcomes (9)

  1. Measurement of muscle fasciculations using an ultrasound device

    Each peripheral muscle will be screened during 30 seconds

    Measured: 3 months

  2. Measurement of muscle strength using Medical Research Council Scale (MRCs)

    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

    Measured: 3 months

  3. Measurement Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-r)

    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)
    5. 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.

    Measured: 3 months

  4. Measuring Forced Vital Capacity

    This volume expressed in liters will be measured in supine and seated positions.

    Measured: 3 months

  5. Maximal Inspiratory Pressure (MIP)

    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

    Measured: 3 months

  6. Sniff- nasal inspiratory pressure (SNIP)

    It consists of measuring nasal pressure in an occluded nostril during a maximal sniff performed through the contralateral nostril, expressed in centimeters of water

    Measured: 3 months

  7. Peak Cough Flow (PCF)

    Maximal peak cough flow expressed in liters per minute

    Measured: 3 months

  8. Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)

    Obtained by a radial arterial blood sample and expressed in millimeters of mercury

    Measured: 3 months

  9. Cumulative time percentage with SpO2 under 90% (CT90)

    SpO2 is an estimate of arterial oxygen saturation expressed in percentage under 90% obtained from a nocturnal oximetry

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2018
  2. Study start1 Oct 2018
  3. Primary completion1 Oct 2018
  4. Study completion10 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
26 participants (actual)
Target duration
9 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT03683875
Sponsor's protocol ID
ECO-ELA
Status last verified
Oct 2021
First submitted
12 Sep 2018
Last updated
5 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22239880

  • 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.

    PubMed 20810308

  • 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.

    PubMed 22244867

  • 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.

    PubMed 20392981

  • 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.

    PubMed 17964067

  • 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.

    PubMed 19722256

  • 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.

    PubMed 25155020

  • 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.

    PubMed 21815172

  • Martinez-Paya JJ, Del Bano-Aledo ME, Rios-Diaz J, Tembl-Ferrairo JI, Vazquez-Costa JF, Medina-Mirapeix F. Muscular Echovariation: A New Biomarker in Amyotrophic Lateral Sclerosis. Ultrasound Med Biol. 2017 Jun;43(6):1153-1162. doi: 10.1016/j.ultrasmedbio.2017.02.002. Epub 2017 Apr 8.

    PubMed 28395965

  • Martinez-Paya JJ, Rios-Diaz J, Del Bano-Aledo ME, Tembl-Ferrairo JI, Vazquez-Costa JF, Medina-Mirapeix F. Quantitative Muscle Ultrasonography Using Textural Analysis in Amyotrophic Lateral Sclerosis. Ultrason Imaging. 2017 Nov;39(6):357-368. doi: 10.1177/0161734617711370. Epub 2017 May 28.

    PubMed 28553752

  • Hiwatani Y, Sakata M, Miwa H. Ultrasonography of the diaphragm in amyotrophic lateral sclerosis: clinical significance in assessment of respiratory functions. Amyotroph Lateral Scler Frontotemporal Degener. 2013 Mar;14(2):127-31. doi: 10.3109/17482968.2012.729595. Epub 2012 Oct 30.

    PubMed 23110443

  • Pinto S, Alves P, Pimentel B, Swash M, de Carvalho M. Ultrasound for assessment of diaphragm in ALS. Clin Neurophysiol. 2016 Jan;127(1):892-897. doi: 10.1016/j.clinph.2015.03.024. Epub 2015 Apr 25.

    PubMed 25971723

  • Fantini R, Mandrioli J, Zona S, Antenora F, Iattoni A, Monelli M, Fini N, Tonelli R, Clini E, Marchioni A. Ultrasound assessment of diaphragmatic function in patients with amyotrophic lateral sclerosis. Respirology. 2016 Jul;21(5):932-8. doi: 10.1111/resp.12759. Epub 2016 Mar 19.

    PubMed 26994409

Questions about this trial

What is this clinical trial studying?

An observational study of Amyotrophic Lateral Sclerosis, run by Hospital General Universitario Santa Lucia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measuring thickness of peripheral muscles using an ultrasound device (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03683875, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.

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Clinical Trial NCT03683875 | AzTrials