NCT03633318

Establishing Muscle Impedance Parameters With Electrical Impedance Myography

Application of Electrical Impedance Myography (EIM) to Establish Muscle Impedance Parameters as a Potential Biomarker of Inclusion Body Myositis (IBM)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 46 Years
• Healthy volunteers: Accepted

Summary

The primary aim of this study is to assess the changes in the impedance parameters of muscles in inclusion body myositis (IBM) through electrical impedance myography (EIM), an emerging non-invasive electrodiagnostic technology. Muscle impedance parameters can potentially serve as an objective biomarker reflecting disease progression and severity.

Detailed description

In this pilot study, the electrical impedance myography (EIM) parameters of individuals with inclusion body myositis (IBM) will be compared with age and sex matched normal data. Along with EIM parameters, clinical outcome measures will be obtained to understand how EIM data correlates with these parameters. A focused study to assess muscle health in IBM patients through EIM is essential to gather further insight into the potential application of this technology as a disease biomarker. Additionally, this investigation will provide critical data for the design of a subsequent biomarker validation study.

Conditions

• IBM
• Inclusion Body Myositis

Interventions

Type	Name	Description
DEVICE	electrical impedance myography (EIM)	EIM is a measure of impedance. EIM is a measure of the obstruction of flow of current through the tissue. It is a completely painless assessment of muscle health.

Timeline

• Start date: 2018-06-19
• Primary completion: 2019-06-30
• Completion: 2019-06-30
• First posted: 2018-08-16
• Last updated: 2020-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study