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Trial record 17 of 54 for:    Inclusion Body Myositis

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 : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE August 13, 2018
First Posted Date  ICMJE August 16, 2018
Last Update Posted Date February 28, 2019
Actual Study Start Date  ICMJE June 19, 2018
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
  • IBM-Functional Rating Scale [ Time Frame: 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.
  • Grip Strength [ Time Frame: 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.
  • 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.
  • 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 participants and healthy controls will undergo this procedure.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Change History Complete list of historical versions of study NCT03633318 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Establishing Muscle Impedance Parameters With Electrical Impedance Myography
Official Title  ICMJE Application of Electrical Impedance Myography (EIM) to Establish Muscle Impedance Parameters as a Potential Biomarker of Inclusion Body Myositis (IBM)
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • IBM
  • Inclusion Body Myositis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Active Comparator: IBM Group
    Participants in this arm will have Inclusion Body Myositis (IBM). All patients will have EIM measurements of selected muscles.
    Intervention: Device: electrical impedance myography (EIM)
  • Control Group
    Participants in this arm will be healthy controls. All participants will have EIM measurements of selected muscles.
    Intervention: Device: electrical impedance myography (EIM)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 46 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Joan Nye, BS (203) 737-7095 joan.nye@yale.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03633318
Other Study ID Numbers  ICMJE 2000023035
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Yale University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP