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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00588432 |
The goal of this proposal is two-fold: (1) to further develop and validate a technology, magnetic resonance elastography (MRE), for quantitatively imaging mechanical properties and tension distribution in muscle and (2) to apply the technique for in vivo evaluation of patients with four common, and clinically significant muscle disorders (spasticity, disuse atrophy, myofascial pain and a metabolic myopathy). These studies will employ a magnetic resonance imaging sequence with synchronous motion-sensitizing gradients to map propagating shear waves in the muscle. The technique will assess the mechanical properties of the muscle and its tension distribution. Specifically, the study can be divided into three specific aims. Aim 1: Optimize MRE methods of acquisition and analysis for the assessment of muscle, including electromechanical drivers, data acquisition techniques, and methods for image analysis. Advanced techniques for very rapid MRE assessment of muscle will continue to be developed. Aim 2: Validate the MRE assessment of muscle properties and tension with phantom, ex-vivo muscle, and Finite Element Modeling (FEM) techniques. Finite Element Analysis will be performed by using both phantom and bovine muscles to better correlate MRE wave-length findings as function of muscle properties, tension and fiber architecture. Aim 3: Study In Vivo Normal and Abnormal Muscle. The MRE technique will be applied in vivo to provide elastographic images of abnormal muscle with known disorders. The patient groups chosen for study are each important in their own right, and furnish unique information across the spectrum of muscular disease and dysfunction. Groups to be studied include individuals with new onset of spasticity following an ischemic, hemispheric stroke, disuse atrophy as a result of immobilization, metabolic (hyperthyroid) myopathy and myofascial pain for trigger point identification. The overall hypothesis of this work is that will bring benefits to both basic research and clinical care.
Condition |
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Stroke Immobilization Myofacial Pain Hyperthyroid Myopathy |
Study Type: | Observational |
Study Design: | Case Control, Cross-Sectional |
Official Title: | Characterization of Skeletal Muscle Using Magnetic Resonance Elastography (MRE) |
Estimated Enrollment: | 300 |
Study Start Date: | April 2003 |
Estimated Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
Hemiparesis as the result of an ischemic hemispheric stroke.
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2
Immobilization following severe Achilles tendon tear or rupture, ankle injury or plantar fascial pain.
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3
Myofascial trigger points in trapezius muscle.
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4
Hyperthyroid Myopathy
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Residents of the community and patients of the study investigators.
Inclusion Criteria:
Normals:
Stroke:
Immobilization:
Myofascial Pain:
Hyperthyroid Myopathy:
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Kai-Nan An, PhD 507-538-1717 an.kainan@mayo.edu | |
Principal Investigator: Kai-Nan An, PhD |
Responsible Party: | May Clinic ( Kai-Nan An ) |
Study ID Numbers: | 2391-02, 5 R01 EB000812 |
Study First Received: | December 26, 2007 |
Last Updated: | January 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00588432 |
Health Authority: | United States: Food and Drug Administration |
Stroke Immobilization Myofacial Pain Hyperthyroid Myopathy |
Cerebral Infarction Facial Pain Facies Stroke Vascular Diseases Central Nervous System Diseases Pain |
Brain Diseases Cerebrovascular Disorders Signs and Symptoms Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Neurologic Manifestations |
Nervous System Diseases Cardiovascular Diseases |