Adult and Juvenile Myositis

  • STATUS
    Recruiting
  • participants needed
    1200
  • sponsor
    National Institute of Environmental Health Sciences (NIEHS)
Updated on 19 August 2021
electrocardiogram
cancer
local anesthetic
corticosteroids
urine tests
chest x-ray
exercise testing
pulmonary function test
nonsteroidal anti-inflammatory drugs
x-rays
MRI
weakness
connective tissue disease
autoimmune disease
muscle biopsy
vision loss
skin biopsy
rheumatism
nonsteroidal anti-inflammatory drugs (nsaids)
rash
dermatomyositis
polymyositis
muscle wasting
impedance testing
myopathy
juvenile dermatomyositis
inclusion body myositis
damage muscles
connective tissue disorder
skin inflammation

Summary

This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability.

Children or adults with polymyositis or dermatomyositis or a related condition may be evaluated under this study. Healthy children or adults will also be enrolled as "controls," for comparison of test results.

All patients will undergo a complete history (including completing some questionnaires) and physical examination, review of medical records, and blood and urine tests. Patients may then choose to participate in an additional 1- to 5-day evaluation, which will include some or all of the following diagnostic, treatment or research procedures:

  1. Standardized muscle strength testing, range of motion of joints and walking (gait) analysis by a physiotherapist; completion of a questionnaire regarding ability to perform daily tasks
  2. Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of a small skin sample under local anesthetic)
  3. Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg muscles
  4. Swallowing studies, including a physical examination and questionnaire on swallowing ability, studies of tongue strength, and ultrasound imaging during swallowing, and possibly, a modified barium swallow
  5. Voice and speech assessment, possibly including computerized voice analysis and laryngoscopy-analysis of the larynx (voice box) using a small rigid scope with a camera placed in the mouth to view and record vocal cord function
  6. Pulmonary function tests (measurement of air moved into and out of the lungs, using a breathing machine) to evaluate lung function and, possibly, chest X-ray
  7. Electrocardiogram (measurement of the electrical activity of the heart) and, possibly, echocardiogram (ultrasound imaging of the heart)
  8. Endocrine evaluation
  9. Eye examination, in patients with vision loss or other eye symptoms
  10. Nutrition assessment to evaluate muscle mass and muscle wasting, including tape measurements or bioelectric impedance testing, a painless procedure in which wires are attached to the extremities with a sticky paste.
  11. Muscle ultrasound.
  12. Electromyography (record of the electrical activity of muscles)
  13. Muscle or skin biopsy (removal of a small piece of muscle tissue for microscopic examination)

All patients may have only a one-time evaluation or may return for one follow-up evaluations (either the 1-day or 3- to 5-day evaluation) over a 1-year period.

Healthy children will undergo a medical history and brief physical examination; blood and urine tests; speech and swallowing studies including questionnaires and physical examination, tongue strength, and ultrasound study; and bioelectric impedance testing. Children 8 to 18 years old may also have exercise testing.

Description

This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability.

Children or adults with polymyositis or dermatomyositis or a related condition may be evaluated under this study. Healthy children or adults will also be enrolled as "controls," for comparison of test results.

All patients will undergo a complete history (including completing some questionnaires) and physical examination, review of medical records, and blood and urine tests. Patients may then choose to participate in an additional 1- to 5-day evaluation, which will include some or all of the following diagnostic, treatment or research procedures:

  1. Standardized muscle strength testing, range of motion of joints and walking (gait) analysis by a physiotherapist; completion of a questionnaire regarding ability to perform daily tasks
  2. Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of a small skin sample under local anesthetic)
  3. Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg muscles
  4. Swallowing studies, including a physical examination and questionnaire on swallowing ability, studies of tongue strength, and ultrasound imaging during swallowing, and possibly, a modified barium swallow
  5. Voice and speech assessment, possibly including computerized voice analysis and laryngoscopy-analysis of the larynx (voice box) using a small rigid scope with a camera placed in the mouth to view and record vocal cord function
  6. Pulmonary function tests (measurement of air moved into and out of the lungs, using a breathing machine) to evaluate lung function and, possibly, chest X-ray
  7. Electrocardiogram (measurement of the electrical activity of the heart) and, possibly, echocardiogram (ultrasound imaging of the heart)
  8. Endocrine evaluation
  9. Eye examination, in patients with vision loss or other eye symptoms
  10. Nutrition assessment to evaluate muscle mass and muscle wasting, including tape measurements or bioelectric impedance testing, a painless procedure in which wires are attached to the extremities with a sticky paste.
  11. Muscle ultrasound.
  12. Electromyography (record of the electrical activity of muscles)
  13. Muscle or skin biopsy (removal of a small piece of muscle tissue for microscopic examination)

All patients may have only a one-time evaluation or may return for one follow-up evaluations (either the 1-day or 3- to 5-day evaluation) over a 1-year period.

Healthy children will undergo a medical history and brief physical examination; blood and urine tests; speech and swallowing studies including questionnaires and physical examination, tongue strength, and ultrasound study; and bioelectric impedance testing. Children 8 to 18 years old may also have exercise testing.

Details
Condition Dermatomyositis, CONNECTIVE TISSUE DISEASE, Myositis, Dermatosis, Polymyositis, INCLUSION BODY MYOSITIS, Dermatomyositis (Connective Tissue Disease), Congenital Skin Diseases, Polymyositis (Inflammatory Muscle Disease), Juvenile Polymyositis, Skin Conditions, Connective Tissue Diseases, Idiopathic Inflammatory Myopathies
Clinical Study IdentifierNCT00017914
SponsorNational Institute of Environmental Health Sciences (NIEHS)
Last Modified on19 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Healthy volunteer subjects for biomarker studies will be gender and age-matched (within 5 years) with a myositis patient, as reasonably close as possible
Volunteer is not related to a myositis patient who is enrolled in the study
Volunteer is in good health, without a recognized systemic rheumatic disorder, autoimmune disease, immune medicated disease, or cancer, and is not taking any anti-inflammatory medicines, including nonsteroidal anti-inflammatory drugs (NSAIDS) or corticosteroids
Volunteer or volunteer s parent/guardian could give assent/informed consent to all or part of the study after full information has been provided

Exclusion Criteria

If Any Yes answer patient is not eligible for study
Volunteer has undergone surgery or had a major trauma within the past 2 months
Volunteer used anti-inflammatory medications within the past 8 weeks of enrollment, including not currently receiving nonsteroidal anti-inflammatory drugs or corticosteroids
Volunteer has been diagnosed with a chronic infectious illness, inflammatory disease, malignancy, cardiac or pulmonary disease, muscle disorder, clotting disorder, metabolic disorder, systemic rheumatic or autoimmune disease, or immune-mediated disease
Volunteer is pregnant (verbally screened for females of child-bearing potential)
Volunteer has a medical illness that in the judgement of the investigators does not allow safe blood draws or other clinical evaluations needed for study participation
Volunteer is cognitively impaired
Volunteer and or the volunteer s parents/legal guardian is unable or unwilling to give informed consent/assent
Volunteer has functional limitations
Volunteer has joint or muscle problems
Note that the following screening activities may be performed to determine
subject
eligibility
Email, written, or telephone communications with prospective subjects
Review of existing medical records
Review of existing imaging studies
Review of existing photographs or videos
Review of existing pathology specimens/reports from a specimen obtained for diagnostic purposes
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