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)
1 other identifier
observational
31
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2018
CompletedFirst Submitted
Initial submission to the registry
August 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedAugust 11, 2020
August 1, 2020
1 year
August 13, 2018
August 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
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
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
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
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
Study Arms (2)
IBM Group
Participants in this arm will have Inclusion Body Myositis (IBM). All patients will have EIM measurements of selected muscles.
Control Group
Participants in this arm will be healthy controls. All participants will have EIM measurements of selected muscles.
Interventions
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.
Eligibility Criteria
Individuals with IBM compared with age and sex matched people of typical health with: 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. .
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale Physicians Building
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bhaskar Roy, MBBS
Yale School of Medicine: Department of Neurology
- PRINCIPAL INVESTIGATOR
Richard J Nowak, MD, MS
Yale School of Medicine: Department of Neurology
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2018
First Posted
August 16, 2018
Study Start
June 19, 2018
Primary Completion
June 30, 2019
Study Completion
June 30, 2019
Last Updated
August 11, 2020
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share