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

Idiopathic Inflammatory Myopathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03918356
• Other study ID #: 2000024786
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: September 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Inflammatory Myopathies
• Muscular Diseases
• Myositis

Intervention

Device:
• electrical impedance myography
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.

Other:
• healthy control group
healthy control

Locations

Country	Name	City	State
United States	Bhaskar Roy	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Manual Muscle Testing Score	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 years
Primary	IBM-Functional rating scale (IBM-FRS)	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.	2 years
Primary	Grip test	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.	2 years
Primary	Get up and go test	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.	2 years
Primary	Six minute walk	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.	2 years
Primary	Quality of Health and Well Being	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.	2 years
Primary	Myositis Intention to Treat Activities Index (MITAX)	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.	2 years
Primary	Physician Global Assessment Score	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.	2 years