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Establishing Muscle Impedance Parameters With Electrical Impedance Myography

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ClinicalTrials.gov Identifier: NCT03633318
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
IBM Inclusion Body Myositis Device: electrical impedance myography (EIM) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants with IBM will be compared with a group matched on sex and age.
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Application of Electrical Impedance Myography (EIM) to Establish Muscle Impedance Parameters as a Potential Biomarker of Inclusion Body Myositis (IBM)
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2019


Arm Intervention/treatment
Active Comparator: IBM Group
Participants in this arm will have Inclusion Body Myositis (IBM). All patients will have EIM measurements of selected muscles.
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.

Control Group
Participants in this arm will be healthy controls. All participants will have EIM measurements of selected muscles.
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.




Primary Outcome Measures :
  1. IBM-Function [ Time Frame: 45 Minutes ]
    IBM Function will be measured using the IBM-Functional rating scale (IBM-FRS). IBM-FRS will be obtained for each IBM participant. Healthy controls will be considered having a score of "0" for comparison purposes.

  2. Grip Strength [ Time Frame: 45 Minutes ]
    Grip strength will be assessed using the Jamar hand dynamometer will be used to assess the grip strength and will be obtained by the physician from both IBM participants and healthy controls. The best of three attempts will be used.

  3. Time to Stand [ Time Frame: 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.

  4. Walking Distance [ Time Frame: 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 patients and healthy controls will undergo this procedure.

  5. Manual Muscle Testing (MMT) Global Score [ Time Frame: 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.



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Ages Eligible for Study:   46 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03633318


Contacts
Contact: Joan Nye, BS (203) 737-7095 joan.nye@yale.edu

Locations
United States, Connecticut
Yale Physicians Building Recruiting
New Haven, Connecticut, United States, 06519
Contact: Joan Nye, BS         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Bhaskar Roy, MBBS Yale School of Medicine: Department of Neurology

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03633318     History of Changes
Other Study ID Numbers: 2000023035
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Yale University:
electrical impedance myography
EIM

Additional relevant MeSH terms:
Myositis
Myositis, Inclusion Body
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases