Ongoing Clinical Trial Testing New Method for Monitoring Duchenne Muscular Dystrophy Progression
A new pilot clinical trial on Duchenne Muscular Dystrophy, entitled “Double Push Acoustic Radiation Force (DP ARF) Ultrasound for Monitoring Muscle Degeneration in Duchenne Muscular Dystrophy,” is now enrolling participants. The trial is a prospective observational study to test the capacity of a new ultrasound-based imaging system – Double-Push Acoustic Radiation Force (DP ARF) ultrasound – in monitoring Duchenne muscular dystrophy progression. This is achieved by a new method capable of detecting changes in both muscle composition and function throughout time, i.e., from early to later stages of the disease. These changes correlate in time with patients’ loss of mobility.
The trial is sponsored by the University of North Carolina, Chapel Hill in collaboration with the National Institute of Neurological Disorders and Stroke (NINDS).
The study’s primary endpoint is to determine DP ARF marginal peak displacement, i.e., a qualitative measurement that describes the nonlinearity in the viscoelasticity of tissues. Each ARF excitation (two in this case) will result in a first and second peak displacement achieved in tissue P1 and P2, respectively. Another measure is ARF-induced displacement remaining at the time of the second push, denoted by D. The viscoelasticity properties of patients tissue is given by the formula MPD = (P2-D)/P1.
As secondary endpoints, the study will determine several key points of Duchenne Muscular Dystrophy, including changes in voluntary isometric contraction, in distance walked in six minutes, time to walk 30 feet, changes in both percentages of degenerative muscle composition and necrotic tissue area, age of loss of ambulation, and others.
The trial was launched in January 2012 and the estimated date of primary outcome data completion is September 2018.
The study cohort will include patient volunteers with Duchenne muscular dystrophy (DMD). Specifically, thirty volunteers (boys with DMD, enrolling at ages 5 (n=10), 7 (n=10), or 9 (n=10)) will with a clinical diagnosis of DMD and clinical onset by age 5 will be considered for enrollment.
Patients who are interested in participating can apply here:
|Contact: Manisha Chopra, BS||919-843-7857||[email protected]|
|Contact: Caterina Gallippi, Ph.D.||919-843-6647||[email protected]|
|United States, North Carolina|
|The University of North Carolina at Chapel Hill Hospitals|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: James Howard, MD 919-966-5522 [email protected]|
|Contact: Manisha Chopra, BS 919-843-7857 [email protected]|