StrokeNCT00588432
Characterization of Skeletal Muscle Using Magnetic Resonance Elastography (MRE)
An observational study of Stroke and Immobilization, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Immobilization, Myofacial Pain
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of the community and patients of the study investigators.
Who may be able to join
- 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
Show all 10Show fewer
- 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).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stroke, Immobilization, Myofacial Pain, Hyperthyroid Myopathy
- Keywords
- Stroke, Immobilization, Myofacial Pain, Hyperthyroid Myopathy
- Medical subject headings
- Stroke, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startApr 2003
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588432
- Sponsor's protocol ID
- 2391-02
- Other IDs
- 5R01EB000812
- Status last verified
- Dec 2009
- First submitted
- 26 Dec 2007
- Last updated
- 4 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Skeletal Muscle Using Magnetic Resonance Elastography (MRE)
- ClinicalTrials.gov ID
- NCT00588432
- Acronym / sponsor ID
- 2391-02
- Conditions
- Stroke, Immobilization, Myofacial Pain, Hyperthyroid Myopathy
- Keywords
- Stroke, Immobilization, Myofacial Pain, Hyperthyroid Myopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 8 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of the community and patients of the study investigators.
Key inclusion criteria (10 listed)
- Healthy individuals
- 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.
- immobilized in a cast (typically 6 weeks) following sugical repair of a severe Achilles tendon tear or rupture, ankle injury or plantar fascial 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.
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2009.
Related trials for Stroke
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Immobilization, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2009; AzTrials last refreshed its copy on 7 Nov 2026.