NCT03683875

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. 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. 2.To verify the relationship between the degenerative peripheral and diaphragmatic neuromuscular changes evaluated by ultrasonography and changes in clinical scales frequently used.
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

November 5, 2021

Status Verified

October 1, 2021

Enrollment Period

Same day

First QC Date

September 12, 2018

Last Update Submit

October 28, 2021

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (5)

  • 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.

    3 months

  • 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.

    3 months

  • 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.

    3 months

  • 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

    3 months

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

    Displacement of the right diaphragm dome

    3 months

Secondary Outcomes (9)

  • Measurement of muscle fasciculations using an ultrasound device

    3 months

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

    3 months

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

    3 months

  • Measuring Forced Vital Capacity

    3 months

  • Maximal Inspiratory Pressure (MIP)

    3 months

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with Amyotrophic Lateral Sclerosis

You may qualify if:

  • Definite ALS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Santa Lucia

Cartagena, Murcia, 30202, Spain

Location

Related Publications (13)

  • 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.

    PMID: 22239880BACKGROUND

  • 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.

    PMID: 20810308BACKGROUND

  • 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.

    PMID: 22244867BACKGROUND

  • 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.

    PMID: 20392981BACKGROUND

  • 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.

    PMID: 17964067BACKGROUND

  • 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.

    PMID: 19722256BACKGROUND

  • 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.

    PMID: 25155020BACKGROUND

  • 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.

    PMID: 21815172BACKGROUND

  • 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.

    PMID: 28395965BACKGROUND

  • 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.

    PMID: 28553752BACKGROUND

  • 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.

    PMID: 23110443BACKGROUND

  • 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.

    PMID: 25971723BACKGROUND

  • 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.

    PMID: 26994409BACKGROUND

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Antonio Tomás Ríos Cortés

    HOSPITAL GENERAL UNIVERSITARIO SANTA LUCIA - SERVICIO MURCIANO DE SALUD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
9 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc Physiotherapist

Study Record Dates

First Submitted

September 12, 2018

First Posted

September 25, 2018

Study Start

October 1, 2018

Primary Completion

October 1, 2018

Study Completion

March 10, 2020

Last Updated

November 5, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)