Status:
COMPLETED
Studying Skeletal Muscle, Heart, and Diaphragm Imaging in Boys With Duchenne Muscular Dystrophy
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Muscular Dystrophy
Muscular Disease
Eligibility:
MALE
5-17 years
Brief Summary
Background: \- Duchenne muscular dystrophy (DMD) is a disease in which the muscles are unable to make the protein dystrophin. Without this protein, the muscles become gradually weaker. A new medicine...
Detailed Description
Objective: Duchenne muscular dystrophy (DMD) is the most frequent inherited fatal childhood disease. Antisense oligonucleotide (AON)-induced exon skipping is a promising therapeutic strategy for DMD ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- DMD Subjects
- Eligible for the parent study
- Willing and able to comply with all protocol requirements and procedures, including MRI without sedation
- Able to give informed assent and parent(s)/legal guardian to give informed consent in writing signed by the subject and/or parent(s)/legal guardian
- Healthy Volunteers
- Must be unaffected by a neuromuscular condition
- Willing and able to comply with all protocol requirements and procedures, including MRI without sedation.
- Able to give informed assent and parent(s)/legal guardian to give informed consent in writing signed by the subject and/or parent(s)/legal guardian.
- EXCLUSION CRITERIA:
- DMD Subjects and Healthy Volunteers
- Having metal objects in his body that are not MRI-safe. These include the following objects: 1) pacemakers or other implanted electrical devices; 2) brain stimulators; 3) some types of dental implants; 4) aneurysm clips (metal clips on the wall of a large artery); 5) metallic prostheses (including metal pins and rods, heart valves, and cochlear implants; 6) implanted delivery pump; 7) permanent eye liner; or 8) shrapnel fragments.
- Having a fear of closed spaces
Exclusion
Key Trial Info
Start Date :
September 15 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 20 2019
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01451281
Start Date
September 15 2011
End Date
May 20 2019
Last Update
May 22 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892