Idiopathic Inflammatory MyopathiesNCT03918356
Application of Electrical Impedance Myography (EIM) as a Potential Biomarker of Idiopathic Inflammatory Myopathies
A study testing electrical impedance myography in people with Idiopathic Inflammatory Myopathies, run by Yale University at 1 site in United States.
Trial summary
1. To assess changes in impedance parameters in Idiopathic Inflammatory Myopathies (IIMs). 2. To assess whether EIM parameters are reflective of disease severity, based on clinical outcome measures of IIMs. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Inflammatory Myopathies
- What is being tested?
- electrical impedance myography
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 30 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 19Show fewer
- 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)
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Electrical Impedance Myography (EIM) to Establish Muscle Impedance Parameters as a Potential Biomarker of Idiopathic Inflammatory Myopathies (IIMs)
- 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.
Read the 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
- Conditions
- Idiopathic Inflammatory Myopathies
- Being tested
- electrical impedance myography, healthy control group
- Medical subject headings
- Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical impedance myographyDevice
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.
healthy control groupOther
healthy control
| Study group | Role | What they receive |
|---|---|---|
| Inclusion Body Myositis patients | Experimental | 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). Receives: Device: electrical impedance myography |
| Idiopathic Inflammatory Myopathies patients | Experimental | 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. Receives: Device: electrical impedance myography |
| control | Placebo comparator | Healthy controls without any known neuromuscular disorders and no family history of Amyotrophic lateral sclerosis (ALS) will be recruited for the study. Receives: Other: healthy control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start1 Jun 2019
- Primary completion30 May 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Inflammatory MyopathiesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bhaskar Roy, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918356
- Sponsor's protocol ID
- 2000024786
- Status last verified
- Sep 2021
- First submitted
- 12 Apr 2019
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Electrical Impedance Myography (EIM) to Establish Muscle Impedance Parameters as a Potential Biomarker of Idiopathic Inflammatory Myopathies (IIMs)
- ClinicalTrials.gov ID
- NCT03918356
- Acronym / sponsor ID
- 2000024786
- Conditions
- Idiopathic Inflammatory Myopathies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inclusion Body Myositis patients | Experimental | Device: electrical impedance myographySubjects 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). |
| Idiopathic Inflammatory Myopathies patients | Experimental | Device: electrical impedance myographySubjects 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. |
| control | Placebo comparator | Other: healthy control groupHealthy controls without any known neuromuscular disorders and no family history of Amyotrophic lateral sclerosis (ALS) will be recruited for the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical impedance myographyElectrical 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. | Device | Idiopathic Inflammatory Myopathies patients, Inclusion Body Myositis patients |
| healthy control grouphealthy control | Other | control |
Primary outcome
Manual Muscle Testing Score
Time frame: 2 years
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)
Time frame: 2 years
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
Time frame: 2 years
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 frame: 2 years
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
Time frame: 2 years
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
Time frame: 2 years
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)
Time frame: 2 years
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
Time frame: 2 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bhaskar Roy, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical impedance myography in people with Idiopathic Inflammatory Myopathies, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manual Muscle Testing Score (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.