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

Yale University

Status: Completed

Conditions: Idiopathic Inflammatory Myopathies

Treatments: Device: electrical impedance myography; Other: healthy control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03918356

2000024786

Details and patient eligibility

About

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.

Full description

1. 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.
2. 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

Enrollment: 5 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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5 participants in 3 patient groups, including a placebo group

Inclusion Body Myositis patients

Experimental group

Description:

Subjects with clinically or clinico-pathologically defined IBM will be included in this study. Patients with consistent clinical and laboratory features including ages 18 to 80 years, duration of symptoms\> 12 months, serum creatine kinases (CK) no greater than 15 times upper limit of normal, prominent weakness of quadriceps and/or finger flexor weakness\>shoulder abduction weakness along with some characteristic histopathological findings of endomysial inflammatory infiltrate, rimmed vacuoles and protein accumulation or 15-18 nm filaments will be considered as clinically or clinicopathologically defined IBM as proposed by the European Neuromuscular Center (ENMC IBM working group, 2013).

Treatment:

Device: electrical impedance myography

Idiopathic Inflammatory Myopathies patients

Experimental group

Description:

Subjects with more than 2 of the following criteria, symmetric proximal weakness, elevated CK, electromyography (EMG) suggesting myositis, muscles biopsy showing inflammatory changes, and typical skin rashes of dermatomyositis (DM) will be recruited as dermatomyositis and polymyositis (DM/PM) based on Bohan and Peter criteria.

Treatment:

Device: electrical impedance myography

control

Placebo Comparator group

Description:

Healthy controls without any known neuromuscular disorders and no family history of Amyotrophic lateral sclerosis (ALS) will be recruited for the study.

Treatment:

Other: healthy control group