Establishing Muscle Impedance Parameters With Electrical Impedance Myography

Completed

• Conditions: Inclusion Body Myositis; IBM
• Interventions: Device: electrical impedance myography (EIM)

• Registration Number: NCT03633318
• Lead Sponsor: Yale University

Brief 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.

Study Timeline

• Study Start: 2018-06-19
• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-16
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-07
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IBM Group	electrical impedance myography (EIM)	Participants in this arm will have Inclusion Body Myositis (IBM). All patients will have EIM measurements of selected muscles.
Control Group	electrical impedance myography (EIM)	Participants in this arm will be healthy controls. All participants will have EIM measurements of selected muscles.

Primary Outcome Measures

Name	Time	Method
Walking Distance	45 Minutes	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.
IBM-Functional Rating Scale	45 Minutes	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.
Time to Stand	45 Minutes	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.
Grip Strength	45 Minutes	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.
Manual Muscle Testing (MMT) Global Score	45 Minutes	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.

Trial Locations

Locations (1)

Yale Physicians Building; 🇺🇸 New Haven, Connecticut, United States