Establishing Muscle Impedance Parameters With Electrical Impedance Myography

Inclusion Body Myositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03633318
• Other study ID #: 2000023035
• Status: Completed
• Start date: June 19, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 46 Years and older

Eligibility

Inclusion Criteria:

• Clinico-pathologically defined IBM in the absence of any other significant neurological problem or cognitive dysfunction.

• Healthy controls will be age and gender-matched to the enrolled IBM patients.

Exclusion Criteria for both IBM and control group:

• 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

• IBM
• Inclusion Body Myositis
• Myositis
• Myositis, Inclusion Body

Intervention

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.

Locations

Country	Name	City	State
United States	Yale Physicians Building	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	IBM-Functional Rating Scale	Physical functioning in daily life will be measured using the IBM-Functional rating scale (IBM-FRS). IBM-FRS will be obtained for both IBM participants and healthy controls.	45 Minutes
Primary	Grip Strength	Grip strength will be assessed using the Jamar hand dynamometer and will be obtained by the physician from both IBM participants and healthy controls. The best of three attempts will be used.	45 Minutes
Primary	Time to Stand	Time to stand will be measured using the "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. These results will be obtained by the physician from both IBM participants and healthy controls.	45 Minutes
Primary	Walking Distance	Distance walked by a participant in 6 minutes will be measured. Given the general disability of many IBM participants, rather than utilizing two trials, a 2-minute "practice" walk will be performed before the actual test, to familiarize the participant with the task to be performed. Both IBM participants and healthy controls will undergo this procedure.	45 Minutes
Primary	Manual Muscle Testing (MMT) Global Score	This is a hands-on assessment that will use the Medical Research Council muscle scales (MRC) to score the strength of the following muscle groups that may be involved in IBM: neck flexor, extensor, deltoid, biceps, triceps, wrist extensor, wrist flexors, finger long and short flexors, finger extensors, hip flexors, hip adductors, hip abductors, knee extensors, knee flexors, ankle dorsi and planti flexors. MRC scores will be obtained by the physician from both IBM participants and healthy controls. A global score can be calculated and will be used. 0 (none) = no contraction, 1 (trace) = visible contraction with no motion, 2 (poor) = full range of motion, gravity eliminated, 3 (fair) = full range of motion against gravity, 4 (good) = full range of motion against gravity, moderate resistance, 5 (normal) = full range of motion against gravity, maximum resistance.	45 Minutes