- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00588432
Characterization of Skeletal Muscle Using Magnetic Resonance Elastography (MRE)
December 3, 2009 updated by: Mayo Clinic
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Residents of the community and patients of the study investigators.
Description
Inclusion Criteria:
Normals:
- Healthy individuals
Stroke:
- a first stroke (i.e., a unilateral, ischemic hemispheric stroke) within the previous one to two months, ability to cooperate and follow simple commands, and gastrocsoleous strength in the affected lower extremity of between trace and 50% of normal.
Immobilization:
- immobilized in a cast (typically 6 weeks) following sugical repair of a severe Achilles tendon tear or rupture, ankle injury or plantar fascial pain
Myofascial Pain:
- history of pain in trapezius confirmed by clincal examination. The examiner will perform snapping palpation over the MFTP. If a localized, transient contraction is observed, the response is considered to be positive and the subject will be considered eligible for entry into the study.
Hyperthyroid Myopathy:
- clinical assessment in combination with a serum hormone profile of increased Free Thyroxine (FT4) and Triiodothyronine (T3) in the face of suppressed levels of Thyroid Stimulating Hormone (TSH).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
December 26, 2007
First Submitted That Met QC Criteria
January 7, 2008
First Posted (Estimate)
January 8, 2008
Study Record Updates
Last Update Posted (Estimate)
December 4, 2009
Last Update Submitted That Met QC Criteria
December 3, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2391-02
- 5R01EB000812 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.