Characterization of Skeletal Muscle Using Magnetic Resonance Elastography (MRE)

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00588432
First received: December 26, 2007
Last updated: December 3, 2009
Last verified: December 2009
  Purpose

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
Stroke
Immobilization
Myofacial Pain
Hyperthyroid Myopathy

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Characterization of Skeletal Muscle Using Magnetic Resonance Elastography (MRE)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Estimated Enrollment: 300
Study Start Date: April 2003
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Hemiparesis as the result of an ischemic hemispheric stroke.
2
Immobilization following severe Achilles tendon tear or rupture, ankle injury or plantar fascial pain.
3
Myofascial trigger points in trapezius muscle.
4
Hyperthyroid Myopathy

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Residents of the community and patients of the study investigators.

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00588432

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Kai-Nan An, May Clinic
ClinicalTrials.gov Identifier: NCT00588432     History of Changes
Other Study ID Numbers: 2391-02, 5 R01 EB000812
Study First Received: December 26, 2007
Last Updated: December 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Stroke
Immobilization
Myofacial Pain
Hyperthyroid Myopathy

Additional relevant MeSH terms:
Muscular Diseases
Stroke
Facial Pain
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pain
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014