Characterization of Skeletal Muscle Using Magnetic Resonance Elastography (MRE)

Stroke Clinical Trial

Official title:

Characterization of Skeletal Muscle Using Magnetic Resonance Elastography (MRE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00588432
• Other study ID #: 2391-02
• Secondary ID: 5R01EB000812
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: December 3, 2009
• Start date: April 2003
• Est. completion date: September 2009

Study information

• Verified date: December 2009
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hyperthyroid Myopathy
• Hyperthyroidism
• Immobilization
• Myofacial Pain
• Stroke

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

External Links

•   Mayo Clinic Clinical Trials