Application of Electrical Impedance Myography (EIM) as a Potential Biomarker of Idiopathic Inflammatory Myopathies

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03918356
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Yale University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bhaskar Roy, MD
Principal Investigator Affiliation Yale University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Inflammatory Myopathies
Additional Details

1. 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. 2. 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

Arms & Interventions

Arms

Experimental: Inclusion Body Myositis patients

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).

Experimental: Idiopathic Inflammatory Myopathies patients

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.

Placebo Comparator: control

Healthy controls without any known neuromuscular disorders and no family history of Amyotrophic lateral sclerosis (ALS) will be recruited for the study.

Interventions

Device: - electrical impedance myography

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.

Other: - healthy control group

healthy control

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bhaskar Roy, New Haven, Connecticut

Status

Recruiting

Address

Bhaskar Roy

New Haven, Connecticut, 06510

Site Contact

Bhaskar Roy, MD

[email protected]

203-785-6577