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Home > "M" Clinical Trials Conditions > Myositis in Children  Myositis in Children
Myositis in Children
For Condition: Polymyositis,Dermatomyositis,Idiopathic Inflammatory Myopathy,Healthy
Status: Recruiting
Sponsor(s): National Institute of Environmental Health Sciences (NIEHS) ,
Synopsis: This study will evaluate subjects with 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 under 18 years of age with polymyositis or dermatomyositis or a related condition, or adults with onset of these diseases during childhood may be evaluated under this study. Healthy children will also be enrolled as "controls," for comparison of test results. All patients will undergo a 1-day evaluation with 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 3- 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. Exercise bicycle testing in children 8 to 18 years of age (exercising for up to 12 minutes while heart rate, blood pressure, electrocardiogram, and oxygen uptake are monitored). 12. Electromyography (record of the electrical activity of muscles) 13. Muscle 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 two or three 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: This protocol is designed to extend our description of the idiopathic inflammatory myopathies (IIM) to children with juvenile dermatomyositis, polymyositis and other IIM. This study will attempt to delineate groups of patients with similar prognoses who share common clinical features, immunogenetics and autoantibodies; to develop an objective, comprehensive assessment tool of disease activity and chronicity which could be used to assess efficacy in future therapeutic trials; and to obtain specimens for study of the immunologic abnormalities, pathogenesis, and etiology of childhood IIM. Often the diagnosis of an IIM can be confused with other illness such as dystrophies or metabolic myopathies. Therefore, we will evaluate children who are referred with a preliminary diagnosis of an IIM or who have muscle weakness, myalgias, or an elevated creatine phosphokinase (CK) without an established diagnosis. Children with IIM and adult patients with juvenile-onset IIM undergo a comprehensive evaluation at NIH to collect epidemiologic and clinical data and laboratory specimens; these materials may be used for research purposes as well as to confirm a diagnosis of IIM. Some patients may elect to participate in serial clinical evaluations at the NIH to assess the clinical course of the disease, including the extent and severity of their illness. The data collected in this study will be used to develop a comprehensive clinical disease activity assessment tool that may benefit the patient by providing a thorough medical evaluation of their condition and treatment recommendations to their referring physicians.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Meet probable or definite criteria for IIM by Bohan and Peter, and age less than 18 years at diagnosis of an IIM. Ability of Patient or parent/guardian to give informed consent to all or part of the study after full information has been provided. EXCLUSION CRITERIA: Severe medical diseases requiring intensive care or any other conditions in which drawing the amount of blood required or undergoing procedures needed for the study is not deemed medically appropriate by the treating physician or the principal investigator.
Total Enrollment: 230
Location and Contact Information:
National Institute of Environmental Health Sciences (NIEHS) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 940165; 94-E-0165
Study Start Date: June 8, 1994
Record last reviewed: June 4, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017914
Other Healthy Studies:
1. Phase I Trial of Smallpox Vaccine
2. Motor Learning in Stroke Patients and Healthy Volunteers
3. Cytokine Production Patterns in Patients with Systemic Mastocytosis Compared with Atopic Dermatitis and Healthy Individuals
4. Positron Emission Tomography (PET) to Study Brain Signaling
5. Infant's Examination and Manipulation of Objects
Related Studies:
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Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Myositis in Children
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