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Completed

NCT Number: NCT03918356

Application of Electrical Impedance Myography (EIM) as a Potential Biomarker of Idiopathic Inflammatory Myopathies

1. To assess changes in impedance parameters in Idiopathic Inflammatory Myopathies (IIMs). 2. To assess whether EIM parameters are reflective of disease severity, based on clinical outcome measures of IIMs.

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Key information

Conditions

Idiopathic Inflammatory Myopathies Muscular Diseases Musculoskeletal Diseases Myositis Nervous System Diseases Neuromuscular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bhaskar Roy

New Haven, Connecticut, 06510, United States

About this study

  • To assess changes in impedance parameters in Idiopathic Inflammatory Myopathies (IIMs) There are structural and compositional changes in muscles, such as edema, adipose infiltration, and/or atrophy, in IIMs. Electrical impedance myography (EIM) is sensitive to such changes. EIM parameters will be different when compared to healthy controls in IIMs.
  • To assess whether EIM parameters are reflective of disease severity, based on clinical outcome measures of IIMs.

Clinical outcome measures reflect on disease severity which is an indirect measure of muscle involvement in IIMs. If EIM parameters correlate with clinical outcome measure, it would indirectly prove that EIM can reflect disease severity in IIMs

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • duration of weakness >12 months.
  • ages 18 to 80 years old.
  • serum CK level no greater than 15 times the upper limit of normal.
  • quadriceps weakness >hip flexor weakness and/or finger flexor weakness >shoulder abduction weakness.
  • one or more of the following pathological findings:
  • endomysial inflammatory infiltrate.
  • rimmed vacuoles.
  • protein accumulation or 15-18 mm filaments.

DM/PM inclusion criteria:

  • ages 18 to 80
  • Symmetric proximal weakness
  • Elevated CK
  • EMG suggestive of myopathy with evidence of muscle membrane irritation
  • Muscle biopsy suggestive of inflammatory myositis (degeneration, regeneration, necrosis, and interstitial mononuclear infiltrates)
  • Typical skin rashes of DM (Heliotrope rash or Gottron sign)

Key inclusion criteria for the control group:

  • no active neuromuscular disorders or known history of neuromuscular disorders.
  • no sign or symptoms of muscle weakness.
  • no family history of muscular dystrophies or ALS.
  • ages 18 to 80

Exclusion criteria

  • Patients with decompensated congestive heart failure
  • Patients with chronic kidney disease on hemodialysis
  • Patients with active cancer on chemotherapy or radiotherapy
  • Patients with severe disease who are already wheel chair bound

Treatment and study plan

Electrical Impedance Myography

Device

Electrical impedance myography (EIM) is a new electrodiagnostic method of quantitative muscle evaluation. It utilizes concepts of bio impedance, the ability of biological tissue to impede externally applied electrical current.

Healthy Control Group

Other

healthy control

Primary outcomes

  1. Manual Muscle Testing Score

    Time frame: 2 years

    This scale reflects on muscle strength. It is based on Medical Research Council scale for muscle power, where muscle strength can have a score of 0-5 (0 means no strength and 5 means full strength).Several muscles are examined in Manual Muscle Testing (MMT) and the total strength is reported as the sum of the Medical Research Council (MRC) muscles scale score of each muscles. Total MMT score for this study can range from 0-160, where 0 means no strength in any muscles and 160 means full strength in all the muscles examined.

  2. IBM-Functional rating scale (IBM-FRS)

    Time frame: 2 years

    This scale measure the limitations in daily life from IBM. It ask 10 questions regarding the activities of daily life and each question is scored between 0-4 (Where 4 means no difficulty and 0 means maximum difficulty). Total score can vary from 0-40, and 40 means no limitations in daily life from IBM.

  3. Grip test

    Time frame: 2 years

    A change in grip strength using a Jamar hand dynamometer to assess the grip strength in every participant. Best of three attempts will be used.

  4. Get up and go test

    Time frame: 2 years

    Time will be measured for a participant to stand up from a chair (using arms if necessary), walk 3 meters, turn around, return to the chair, and sit down. The better of two trials will be used.

  5. Six minute walk

    Time frame: 2 years

    Distance walked in 6 minutes will be measured. This has been used as a primary and secondary outcome measures in several clinical trials in various neuromuscular disorders.

  6. Quality of Health and Well Being

    Time frame: 2 years

    Short Form-36 (SF-36) is a measure of the global quality of health and well-being. The SF-36 is an eight-scaled score, which are the weighted sums of the questions in their corresponding section. Each scale can be transformed into a 0-100 scale. Lower score means more disability.

    SF-36 will be scored utilizing a standardized scoring manual. We will obtain a physical component summary scale and a mental component summary scale.

  7. Myositis Intention to Treat Activities Index (MITAX)

    Time frame: 2 years

    MITAX is a scale assessing the extra-muscular disease severity of myositis. It contains 24 questions covering 7 extra muscular organ systems. Each question is scored between 0-4, where 0 = not present, 1= improving, 2= same, 3= worse, and 4= new. This score is then converted to a final score ranging from A-E for each system based on a predefined scoring schema. Total MITAX score can range between 0 to 54.

  8. Physician Global Assessment Score

    Time frame: 2 years

    This is recorded on a 10-cm visual analog scale (VAS) by the physician at the time of evaluation. The score should reflect on the individual's appearance, medical history, physical examination, laboratory testing, and prescribed medical therapy. In this scale 0 means no evidence of disease related damage and 10 means extremely severe damage.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Application of Electrical Impedance Myography (EIM) to Establish Muscle Impedance Parameters as a Potential Biomarker of Idiopathic Inflammatory Myopathies (IIMs)

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 17, 2019
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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