NCT04233255

Brief Summary

The study aims to provide a timely update on the role of combining clinical and neuromuscular ultrasound assessments in diagnosis and follow-up of various muscle diseases in clinical practice over 12 months period, and correlating US findings with functional scales, biochemical and electrophysiological studies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Longer than P75 for all trials

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

January 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

January 15, 2020

Last Update Submit

February 22, 2025

Conditions

UltrasoundMuscle Disease

Keywords

UltrasoundMuscleElectrophysiology

Outcome Measures

Primary Outcomes (1)

  • The rate of decline of patients with muscle disorder versus normal subjects as assessed by quantitative ultrasound measurements and electrophysiology studies.

    With the successful completion of this aim, the investigators will establish that alterations in both quantitative ultrasound and electromyography will provide meaningful measures of disease progression.

    up to 12 months

Secondary Outcomes (3)

  • Rate of change in Functional assessment of muscle weakness

    up to 12 months

  • Rate of change in manual muscle strength testing by EXPANDED MRC (The modified Medical Research Council)

    up to 12 months

  • Rate of change of serum CPK and CK-MM levels

    up to 12 months

Study Arms (2)

Patients with muscle disease(myositis, hereditary myopathy)

Includes 64 symptomatic patients with muscle disease subdivided into two subgroups (a) 10 patients with acute inflammatory myositis; And (b 545patients with hereditary myopathy. The patients will be subjected to neuromuscular ultrasound (US) and electrophysiology at baseline,after 6 months and after 12 months. The number and location of studied muscles will be determined according to pattern of clinical presentation.

Device: Neuromuscular Ultrasound (US)Device: Electrophysiological studiesDiagnostic Test: Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase.

Healthy volunteers as control group

Includes 64 healthy volunteers as control group. They will be subjected to neuromuscular ultrasound (US) and electrophysiology at baseline. Their age, sex, number and location of studied muscles will be matched with patients' group.

Device: Neuromuscular Ultrasound (US)Device: Electrophysiological studiesDiagnostic Test: Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase.

Interventions

Neuromuscular Ultrasound (US)DEVICE

Quantitative ultrasound measurements will be performed to studied muscles according to a standard protocol; for each muscle three consecutive measurements will be made to minimize variation in echo intensity during analysis .The captured images will be analyzed offline for echo intensity by means of computer-assisted grayscale histogram analysis.The study will be performed using My lab 7 ultrasound system (Esaote company, Italy) that is equipped by 7-19 MHz linear array transducer and color and power Doppler. Technique: evaluation of studied muscles for echo intensity (ECHO), quantitative assessments of echointensity, muscle perfusion, transverse and longitudinal sections of the muscle and its thickness at rest and during maximal voluntary contractions (MVC), overlying subcutaneous fat, cross-sectional area (CSA), and angled fibers of pennate muscles.

Healthy volunteers as control groupPatients with muscle disease(myositis, hereditary myopathy)
Electrophysiological studiesDEVICE

Includes: Motor and sensory nerve conduction study, F-wave and H-reflex study to assess the proximal roots, Electromyography (EMG) of the studied muscles. using machine: recordings will be performed with a Nihon Kohden equipment (model 7102) with the following parameters: sweep time 8 ms/D, sensitivity 0.5 mV/D, low frequency filter 2 Hz, high frequency filter 10 kHz, stimulation duration 0.1 ms and stimulation frequency 1 Hz.

Healthy volunteers as control groupPatients with muscle disease(myositis, hereditary myopathy)
Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase.DIAGNOSTIC_TEST

measured in U/L using ELISA.

Healthy volunteers as control groupPatients with muscle disease(myositis, hereditary myopathy)

Eligibility Criteria

Age2 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study will be performed on 2 groups Group (I): 32 patients diagnosed to have muscle disease subdivided into two subgroups (a)16 patients with acute inflammatory myositis; And (b)16 patients with hereditary myopathy. Group (II): including 32 healthy volunteers matching age and sex as control group.

You may qualify if:

  • Males and females.
  • years old.
  • For patients with acute inflammatory myositis: patients presenting with characteristic picture of acute inflammatory myositis according to the myositis association 2019.
  • For patients with acute inflammatory myositis: newly diagnosed patients within one month from onset of disease.
  • All patients not received any previous specific treatment for myopathy.

You may not qualify if:

  • Patients with clinically or electrophysiologically suspected other neuromuscular conditions that mimic myopathy such as motor neuron disease, neuromuscular junction disorders.
  • Patients with secondary causes of myopathies; as drug induced, endocrinal disorders like diabetes mellitus and hypothyroidism or metabolic myopathy.
  • Patients who received any previous specific treatment for myopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Publications (8)

  • Wattjes MP, Kley RA, Fischer D. Neuromuscular imaging in inherited muscle diseases. Eur Radiol. 2010 Oct;20(10):2447-60. doi: 10.1007/s00330-010-1799-2. Epub 2010 Apr 27.

    PMID: 20422195RESULT

  • Boon A. Ultrasonography and electrodiagnosis: are they complementary techniques? PM R. 2013 May;5(5 Suppl):S100-6. doi: 10.1016/j.pmrj.2013.03.014. Epub 2013 Mar 19.

    PMID: 23524068RESULT

  • Chiaramonte R, Bonfiglio M, Castorina EG, Antoci SAM. The primacy of ultrasound in the assessment of muscle architecture: precision, accuracy, reliability of ultrasonography. Physiatrist, radiologist, general internist, and family practitioner's experiences. Rev Assoc Med Bras (1992). 2019 Feb;65(2):165-170. doi: 10.1590/1806-9282.65.2.165.

    PMID: 30892439RESULT

  • O'Sullivan PJ, Gorman GM, Hardiman OM, Farrell MJ, Logan PM. Sonographically guided percutaneous muscle biopsy in diagnosis of neuromuscular disease: a useful alternative to open surgical biopsy. J Ultrasound Med. 2006 Jan;25(1):1-6. doi: 10.7863/jum.2006.25.1.1.

    PMID: 16371549RESULT

  • Kubinova K, Dejthevaporn R, Mann H, Machado PM, Vencovsky J. The role of imaging in evaluating patients with idiopathic inflammatory myopathies. Clin Exp Rheumatol. 2018 Sep-Oct;36 Suppl 114(5):74-81. Epub 2018 Oct 1.

    PMID: 30296982RESULT

  • Mah JK, van Alfen N. Neuromuscular Ultrasound: Clinical Applications and Diagnostic Values. Can J Neurol Sci. 2018 Nov;45(6):605-619. doi: 10.1017/cjn.2018.314.

    PMID: 30430964RESULT

  • Barohn RJ, Dimachkie MM, Jackson CE. A pattern recognition approach to patients with a suspected myopathy. Neurol Clin. 2014 Aug;32(3):569-93, vii. doi: 10.1016/j.ncl.2014.04.008.

    PMID: 25037080RESULT

  • Vanhoutte EK, Faber CG, van Nes SI, Jacobs BC, van Doorn PA, van Koningsveld R, Cornblath DR, van der Kooi AJ, Cats EA, van den Berg LH, Notermans NC, van der Pol WL, Hermans MC, van der Beek NA, Gorson KC, Eurelings M, Engelsman J, Boot H, Meijer RJ, Lauria G, Tennant A, Merkies IS; PeriNomS Study Group. Modifying the Medical Research Council grading system through Rasch analyses. Brain. 2012 May;135(Pt 5):1639-49. doi: 10.1093/brain/awr318. Epub 2011 Dec 20.

    PMID: 22189568RESULT

Related Links

MeSH Terms

Conditions

Muscular Diseases

Interventions

Electrophysiologic Techniques, Cardiac

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Nageh F. El-Gammal, Doctorate

    Assiut University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 18, 2020

Study Start

April 1, 2020

Primary Completion

April 4, 2024

Study Completion

July 1, 2024

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)