NCT00588432

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 8, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

December 4, 2009

Status Verified

December 1, 2009

Enrollment Period

6.4 years

First QC Date

December 26, 2007

Last Update Submit

December 3, 2009

Conditions

Keywords

StrokeImmobilizationMyofacial PainHyperthyroid Myopathy

Study Arms (4)

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 Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Residents of the community and patients of the study investigators.

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

StrokeFacial Pain

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 8, 2008

Study Start

April 1, 2003

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

December 4, 2009

Record last verified: 2009-12

Locations