Back to resultsApplication of Electrical Impedance Myography (EIM) as a Potential Biomarker of Idiopathic Inflammatory Myopathies
Primary Purpose
Idiopathic Inflammatory Myopathies
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
electrical impedance myography
healthy control group
Sponsored by
About this trial
This is an interventional other trial for Idiopathic Inflammatory Myopathies
Eligibility Criteria
Inclusion Criteria:
- duration of weakness >12 months.
- ages 18 to 80 years old.
- serum CK level no greater than 15 times the upper limit of normal.
- quadriceps weakness >hip flexor weakness and/or finger flexor weakness >shoulder abduction weakness.
- one or more of the following pathological findings:
- endomysial inflammatory infiltrate.
- rimmed vacuoles.
- protein accumulation or 15-18 mm filaments.
DM/PM inclusion criteria:
- ages 18 to 80
- Symmetric proximal weakness
- Elevated CK
- EMG suggestive of myopathy with evidence of muscle membrane irritation
- Muscle biopsy suggestive of inflammatory myositis (degeneration, regeneration, necrosis, and interstitial mononuclear infiltrates)
- Typical skin rashes of DM (Heliotrope rash or Gottron sign)
Key inclusion criteria for the control group:
- 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.
- ages 18 to 80
Exclusion Criteria:
- 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
Sites / Locations
- Bhaskar Roy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Inclusion Body Myositis patients
Idiopathic Inflammatory Myopathies patients
control
Arm Description
Subjects with clinically or clinico-pathologically defined IBM will be included in this study. Patients with consistent clinical and laboratory features including ages 18 to 80 years, duration of symptoms> 12 months, serum creatine kinases (CK) no greater than 15 times upper limit of normal, prominent weakness of quadriceps and/or finger flexor weakness>shoulder abduction weakness along with some characteristic histopathological findings of endomysial inflammatory infiltrate, rimmed vacuoles and protein accumulation or 15-18 nm filaments will be considered as clinically or clinicopathologically defined IBM as proposed by the European Neuromuscular Center (ENMC IBM working group, 2013).
Subjects with more than 2 of the following criteria, symmetric proximal weakness, elevated CK, electromyography (EMG) suggesting myositis, muscles biopsy showing inflammatory changes, and typical skin rashes of dermatomyositis (DM) will be recruited as dermatomyositis and polymyositis (DM/PM) based on Bohan and Peter criteria.
Healthy controls without any known neuromuscular disorders and no family history of Amyotrophic lateral sclerosis (ALS) will be recruited for the study.
Outcomes
Primary Outcome Measures
Manual Muscle Testing Score
This scale reflects on muscle strength. It is based on Medical Research Council scale for muscle power, where muscle strength can have a score of 0-5 (0 means no strength and 5 means full strength).Several muscles are examined in Manual Muscle Testing (MMT) and the total strength is reported as the sum of the Medical Research Council (MRC) muscles scale score of each muscles. Total MMT score for this study can range from 0-160, where 0 means no strength in any muscles and 160 means full strength in all the muscles examined.
IBM-Functional rating scale (IBM-FRS)
This scale measure the limitations in daily life from IBM. It ask 10 questions regarding the activities of daily life and each question is scored between 0-4 (Where 4 means no difficulty and 0 means maximum difficulty). Total score can vary from 0-40, and 40 means no limitations in daily life from IBM.
Grip test
A change in grip strength using a Jamar hand dynamometer to assess the grip strength in every participant. Best of three attempts will be used.
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.
Six minute walk
Distance walked in 6 minutes will be measured. This has been used as a primary and secondary outcome measures in several clinical trials in various neuromuscular disorders.
Quality of Health and Well Being
Short Form-36 (SF-36) is a measure of the global quality of health and well-being. The SF-36 is an eight-scaled score, which are the weighted sums of the questions in their corresponding section. Each scale can be transformed into a 0-100 scale. Lower score means more disability.
SF-36 will be scored utilizing a standardized scoring manual. We will obtain a physical component summary scale and a mental component summary scale.
Myositis Intention to Treat Activities Index (MITAX)
MITAX is a scale assessing the extra-muscular disease severity of myositis. It contains 24 questions covering 7 extra muscular organ systems. Each question is scored between 0-4, where 0 = not present, 1= improving, 2= same, 3= worse, and 4= new. This score is then converted to a final score ranging from A-E for each system based on a predefined scoring schema. Total MITAX score can range between 0 to 54.
Physician Global Assessment Score
This is recorded on a 10-cm visual analog scale (VAS) by the physician at the time of evaluation. The score should reflect on the individual's appearance, medical history, physical examination, laboratory testing, and prescribed medical therapy. In this scale 0 means no evidence of disease related damage and 10 means extremely severe damage.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03918356
Brief Title
Application of Electrical Impedance Myography (EIM) as a Potential Biomarker of Idiopathic Inflammatory Myopathies
Official Title
Application of Electrical Impedance Myography (EIM) to Establish Muscle Impedance Parameters as a Potential Biomarker of Idiopathic Inflammatory Myopathies (IIMs)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
May 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess changes in impedance parameters in Idiopathic Inflammatory Myopathies (IIMs).
To assess whether EIM parameters are reflective of disease severity, based on clinical outcome measures of IIMs.
Detailed Description
To assess changes in impedance parameters in Idiopathic Inflammatory Myopathies (IIMs) There are structural and compositional changes in muscles, such as edema, adipose infiltration, and/or atrophy, in IIMs. Electrical impedance myography (EIM) is sensitive to such changes. EIM parameters will be different when compared to healthy controls in IIMs.
To assess whether EIM parameters are reflective of disease severity, based on clinical outcome measures of IIMs.
Clinical outcome measures reflect on disease severity which is an indirect measure of muscle involvement in IIMs. If EIM parameters correlate with clinical outcome measure, it would indirectly prove that EIM can reflect disease severity in IIMs
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Inflammatory Myopathies
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Inclusion Body Myositis patients
Arm Type
Experimental
Arm Description
Subjects with clinically or clinico-pathologically defined IBM will be included in this study. Patients with consistent clinical and laboratory features including ages 18 to 80 years, duration of symptoms> 12 months, serum creatine kinases (CK) no greater than 15 times upper limit of normal, prominent weakness of quadriceps and/or finger flexor weakness>shoulder abduction weakness along with some characteristic histopathological findings of endomysial inflammatory infiltrate, rimmed vacuoles and protein accumulation or 15-18 nm filaments will be considered as clinically or clinicopathologically defined IBM as proposed by the European Neuromuscular Center (ENMC IBM working group, 2013).
Arm Title
Idiopathic Inflammatory Myopathies patients
Arm Type
Experimental
Arm Description
Subjects with more than 2 of the following criteria, symmetric proximal weakness, elevated CK, electromyography (EMG) suggesting myositis, muscles biopsy showing inflammatory changes, and typical skin rashes of dermatomyositis (DM) will be recruited as dermatomyositis and polymyositis (DM/PM) based on Bohan and Peter criteria.
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
Healthy controls without any known neuromuscular disorders and no family history of Amyotrophic lateral sclerosis (ALS) will be recruited for the study.
Intervention Type
Device
Intervention Name(s)
electrical impedance myography
Intervention Description
Electrical impedance myography (EIM) is a new electrodiagnostic method of quantitative muscle evaluation. It utilizes concepts of bio impedance, the ability of biological tissue to impede externally applied electrical current.
Intervention Type
Other
Intervention Name(s)
healthy control group
Intervention Description
healthy control
Primary Outcome Measure Information:
Title
Manual Muscle Testing Score
Description
This scale reflects on muscle strength. It is based on Medical Research Council scale for muscle power, where muscle strength can have a score of 0-5 (0 means no strength and 5 means full strength).Several muscles are examined in Manual Muscle Testing (MMT) and the total strength is reported as the sum of the Medical Research Council (MRC) muscles scale score of each muscles. Total MMT score for this study can range from 0-160, where 0 means no strength in any muscles and 160 means full strength in all the muscles examined.
Time Frame
2 years
Title
IBM-Functional rating scale (IBM-FRS)
Description
This scale measure the limitations in daily life from IBM. It ask 10 questions regarding the activities of daily life and each question is scored between 0-4 (Where 4 means no difficulty and 0 means maximum difficulty). Total score can vary from 0-40, and 40 means no limitations in daily life from IBM.
Time Frame
2 years
Title
Grip test
Description
A change in grip strength using a Jamar hand dynamometer to assess the grip strength in every participant. Best of three attempts will be used.
Time Frame
2 years
Title
Get up and go test
Description
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.
Time Frame
2 years
Title
Six minute walk
Description
Distance walked in 6 minutes will be measured. This has been used as a primary and secondary outcome measures in several clinical trials in various neuromuscular disorders.
Time Frame
2 years
Title
Quality of Health and Well Being
Description
Short Form-36 (SF-36) is a measure of the global quality of health and well-being. The SF-36 is an eight-scaled score, which are the weighted sums of the questions in their corresponding section. Each scale can be transformed into a 0-100 scale. Lower score means more disability.
SF-36 will be scored utilizing a standardized scoring manual. We will obtain a physical component summary scale and a mental component summary scale.
Time Frame
2 years
Title
Myositis Intention to Treat Activities Index (MITAX)
Description
MITAX is a scale assessing the extra-muscular disease severity of myositis. It contains 24 questions covering 7 extra muscular organ systems. Each question is scored between 0-4, where 0 = not present, 1= improving, 2= same, 3= worse, and 4= new. This score is then converted to a final score ranging from A-E for each system based on a predefined scoring schema. Total MITAX score can range between 0 to 54.
Time Frame
2 years
Title
Physician Global Assessment Score
Description
This is recorded on a 10-cm visual analog scale (VAS) by the physician at the time of evaluation. The score should reflect on the individual's appearance, medical history, physical examination, laboratory testing, and prescribed medical therapy. In this scale 0 means no evidence of disease related damage and 10 means extremely severe damage.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
duration of weakness >12 months.
ages 18 to 80 years old.
serum CK level no greater than 15 times the upper limit of normal.
quadriceps weakness >hip flexor weakness and/or finger flexor weakness >shoulder abduction weakness.
one or more of the following pathological findings:
endomysial inflammatory infiltrate.
rimmed vacuoles.
protein accumulation or 15-18 mm filaments.
DM/PM inclusion criteria:
ages 18 to 80
Symmetric proximal weakness
Elevated CK
EMG suggestive of myopathy with evidence of muscle membrane irritation
Muscle biopsy suggestive of inflammatory myositis (degeneration, regeneration, necrosis, and interstitial mononuclear infiltrates)
Typical skin rashes of DM (Heliotrope rash or Gottron sign)
Key inclusion criteria for the control group:
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.
ages 18 to 80
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhaskar Roy, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bhaskar Roy
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Application of Electrical Impedance Myography (EIM) as a Potential Biomarker of Idiopathic Inflammatory Myopathies
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