Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy Research Study specific to Becker Muscular Dystrophy is a natural history study evaluating the disease progression in BMD via the use of MRI, which allows doctors and researchers to look at your muscles.
Take the online screener today to see if this study may be a good fit for you.
Becker Muscular Dystrophy (BMD) is caused by a genetic defect and leads to muscle instability and progressive muscle weakness. The natural history of the disease progression in BMD is not well understood, and drug development and clinical trials have been slow.
Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy Research Study specific to Becker muscular dystrophy is a natural history study evaluating the disease progression in BMD via the use of MRI, which allows doctors and researchers to look at your muscles.
Becker Muscular Dystrophy (BMD) has been largely neglected in therapeutic development, due to its heterogeneity, small patient population, lack of outcome measures and uncertainty surrounding the patterns of disease progression, which may be mutation-dependent.
This is not an interventional study. No treatment will be provided during the course of study participation.
We’re committed to ensuring that all participants can easily access this study.
Participants will meet with experienced researchers and can receive the results at the end of the study.
All ambulatory and non-ambulatory males between the ages of 18-62 years with a previous diagnosis of BMD.
*Other criteria will apply.
Before being able to join this Muscular Dystrophy study, individuals will be screened to find out if they are eligible. If they are eligible and choose to take part in this study, they will:
Have up to 3 visits with dedicated and experienced biomedical researchers over the course of 24 months, who will evaluate disease progression.
Perform functional and MRI assessments throughout the study.
All study-related procedures, including medical tests, functional assessments, biopsy, and MRIs will be provided at no cost to participants.
Magnetic Resonance Imaging (MRI) measures will be performed on legs,
arms, breathing, and/or trunk muscles. After these tests are completed, muscle strength and functional tests such as balance, walking, climbing four steps, and arm movements may be performed. Respiratory (breathing) testing may also be performed. Breaks are provided between tests to avoid fatigue.
We may videotape you during the functional testing portion of this study but will not include your face or head in any of the video recordings. A blood sample will be acquired each visit and a needle muscle biopsy will be performed in two muscles at one of the visits.
There are no costs for you to participate. If this study is a good fit, you will receive all study-related procedures, including medical tests and assessments, all at no cost to you.
Approximately 105 men with BMD, 18-62 years of age.
You will be expected to participate in a total of three visits: baseline, 1 year, and 2 years. On each testing day you are expected to participate for 6-8 hours. In a small group of subjects (n=20) the MR measurements will be repeated on a second day to evaluate the reproducibility of the measures (additional time 2-3 hours).
Your participation in this study will last for a total duration of 24 months. You will be asked to participate in 3 visits over that time (baseline, 12 and 24 months). Each visit will take 6-8 hours.
Participation is completely voluntary and you may discontinue at any time.
This study is being conducted on behalf of the University of Florida and Oregon Health and Science University with trained and qualified specialists.
Clara Health is collaborating with UF and OHSU to provide support to individuals interested in participating in this portion of the Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy specific to Becker muscular dystrophy and connect them with the study team.
During this phase your physician will ensure that this study is a good fit for you based on the eligibility criteria.
During this phase, we will use MRI to measure the muscles of men with BMD and muscles of age matched healthy controls to determine whether this new method can be used to track disease progression and to evaluate whether a drug is effective in BMD. Muscle biopsies will be used to understand how these new measures relate to disease processes within the muscle itself.
We will also measure functional skills such as walking, arm and leg function, and breathing function.
Call toll free at 985-777-4138, email [email protected], or chat with us here.