Magnetic Resonance and Optical Imaging of Dystrophic and Damaged Muscle
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional

Summary: 
      The purpose of this research study is to determine the potential of Optical Imaging
      techniques to detect muscle damage in boys with Duchenne Muscular Dystrophy and unaffected
      exercised muscle. Healthy subjects will undergo two different exercises in opposite forearms
      before any imaging techniques are performed. Boys with Duchenne Muscular Dystrophy will only
      undergo the imaging techniques without exercise.
    

Detailed description: 
      The overall objective of this proposal is to validate the potential of Optical Imaging
      techniques to be able to detect and quantify muscle damage in a population affected by
      Duchenne Muscular Dystrophy, a muscle wasting disease, and in a healthy population that has
      undergone temporal muscle damage resulting from an exercising intervention.

      Duchenne Muscular Dystrophy is a relentlessly progressive degenerative muscle wasting
      disease, clinically characterized by progressive muscle weakness, a loss of ambulation, and
      premature mortality. Currently, no known cure exists and treatments that benefit patients
      diagnosed with Duchenne Muscular Dystrophy are limited. New approaches, such as cell therapy,
      gene transfer, and pharmacological interventions have shown promising results in animal
      models and human studies with great potential to develop as effective therapeutic treatments.
      One of the major limitations of testing these interventions; however. is the lack of
      effective methods to monitor cellular and tissue changes taking place in the response to
      therapy. The ability to determine cellular and tissue specific changes in damaged muscles in
      real time, non-invasively, repeatedly, without exposure to any harmful radiations, with
      minimal patient discomfort, and at low operating cost would enable high throughput and faster
      investigation of potential therapies.

      The proposed study focuses on the development of Optical Imaging technologies in the near
      infrared range of wavelengths to differentiate damaged from normal muscle tissue. Near
      infrared light (700 - 900 nm) has demonstrated the ability to deeply penetrate through
      biological tissue, skin, and muscle without appreciable attenuation or auto-fluorescence.

      The investigators anticipate that Indocyanine Green enhanced Optical Imaging can be used to
      image exercise induced acute muscle damage in healthy individuals and damaged muscle and in
      boys with Duchenne Muscular Dystrophy. It is anticipated that this work may fulfill the need
      for imaging biomarkers that monitor and quantify cellular damage, muscle perfusion, and drug
      delivery - non-invasively, using benign light, repeatedly, and in real time, with the
      intention of accelerating the testing of efficacy in clinical trials for neuromuscular
      disorders. The study is designed to determine the ability of Optical Imaging as a reliable,
      safe, relatively inexpensive, and facile tool to detect and quantify muscle damage.
      Investigators anticipate that this type of imaging modality will provide clinically useful
      information for diagnostic and prognostic purposes in patients with neuromuscular diseases,
      especially boys with Duchenne Muscular Dystrophy.
    

Intervention name(s): Exercising; Optical and Magnetic Resonance Imaging and Spectroscopy
Intervention type(s): Other; Procedure
Intervention description(s): This arm will only include subjects that have a confirmed diagnosis of Duchenne Muscular Dystrophy. Subjects in this arm will not undergo any exercising, and will only be imaged by Optical and Magnetic Resonance Imaging and Spectroscopy techniques at a single time point.; This arm will contain subjects that are not affected by Duchenne Muscular Dystrophy. These subjects will undergo concentric exercising of one forearm, and eccentric exercising of the contralateral forearm. Two days following the exercising, subjects will undergo Optical Imaging and Magnetic Resonance Imaging and Spectroscopy.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Duchenne Muscular Dystrophy; Exercise; Optical Imaging; Magnetic Resonance