Clinical trial NCT03918356: Application of Electrical Impedance Myography (EIM) as a Potential Biomarker of Idiopathic Inflammatory Myopathies
Official title: Application of Electrical Impedance Myography (EIM) to Establish Muscle Impedance Parameters as a Potential Biomarker of Idiopathic Inflammatory Myopathies (IIMs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Inflammatory Myopathies
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Manual Muscle Testing Score
timeFrame: 2 years
measure: IBM-Functional rating scale (IBM-FRS)
timeFrame: 2 years
measure: Grip test
timeFrame: 2 years
measure: Get up and go test
timeFrame: 2 years
measure: Six minute walk
timeFrame: 2 years
measure: Quality of Health and Well Being
timeFrame: 2 years
measure: Myositis Intention to Treat Activities Index (MITAX)
timeFrame: 2 years
measure: Physician Global Assessment Score
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Bhaskar Roy
state: Connecticut
Study officials:
affiliation: Yale University
name: Bhaskar Roy, MD
role: PRINCIPAL_INVESTIGATOR
References: