Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017914
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2001-06-19
Brief Title:
Adult and Juvenile Myositis
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies in the Natural History and Pathogenesis of Childhood-Onset and Adult-Onset Idiopathic Inflammatory Myopathies
Status:
RECRUITING
Status Verified Date:
2024-07-30
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 94-E-0165 | None | None | None |