MRI Study of Musculoskeletal Function



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:5 - Any
Updated:12/27/2018
Start Date:January 16, 2003
Contact:Sara F Sadeghi
Email:sara.sadeghi@nih.gov
Phone:(301) 451-7529

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Virtual Functional Anatomy (VFA)

This study will use magnetic resonance imaging (MRI) and ultrasound images to study how
muscles, tendons, and bones work together to cause motion. The procedure is one of several
tools being developed to characterize normal and impaired musculoskeletal function, with the
goal of developing improved methods of diagnosis and treatment of movement disorders.

Healthy normal volunteers must be age 5 to unlimited, with or without joint impairment, may
be eligible for this study. Volunteers with joint impairment may not have serious injury to
the joint being studied, previous surgery on the joint being studied, or extreme pain at the
joint being studied.

MRI uses a strong magnet and radio waves to create images of the inside of the body. The
subject lies on a long narrow couch inside a metal cylinder (the scanner) for up to 3 hours
while the scanner gathers data. Earplugs are worn to muffle loud noises caused by electrical
switching of radiofrequency circuits used in the scanning process. A special pad or tube may
be placed over or around the region being scanned to improve the quality of the data. The
subject will be asked to repeatedly move a specific joint, such as the knee, for brief
periods, usually less than 5 minutes. The subject can communicate via intercom with the
person performing the study at all times during the procedure, and may request to stop the
study at any time.

The overall goal of this technology development initiative is to greatly advance the clinical
diagnosis and treatment of musculoskeletal impairments as they relate to joint function. The
primary focus of this protocol is to initially develop and ultimately validate a combined set
of tools (virtual functional anatomy - VFA) that will enable the accurate and precise
measurement, analysis and visualization of three-dimensional (3D) static and dynamic
musculoskeletal anatomy (i.e., bone shape, skeletal kinematics, tendon and ligament strain,
muscle force, and joint space) from imaging data. We plan to merge and extend our existing MR
imaging and analysis capabilities with ultrasound imaging and analysis for the development
and implementation of a highly accurate, imaging-based measurement and analysis technique for
the non-invasive quantification of complete joint anatomy and tissue dynamics during
functional movements. In short, we plan to develop a method for creating 3D digital images of
loaded and moving joint tissues (bone, cartilage, and connective tissues) that reveal joint
contact patterns and tissue loads. In conjunction with building this tool, we will evaluate
the variability of bone shape across subjects, the sensitivity of defined joint posture
(translation and rotation of one bone relative to another) to osteo-based coordinate system
definition, and the ability to ultimately use these tools to document and evaluate the
function of normal and impaired joint structures (e.g., ACL rupture, patella tracking
syndrome ) under simulated conditions experienced during activities of daily living.

The principal investigator has previously developed and tested the primary component in the
VFA package, cine-phase contrast and fast-phase contrast (fast-PC) MRI, demonstrating both to
be highly accurate and precise in the measurement of normal 3D knee joint kinematics and
biceps femoris strain. Additional investigators have previously developed techniques for
imaging musculoskeletal structures using ultrasonography, demonstrating these techniques to
be, likewise, highly accurate and precise in the measurement of biomechanical properties of
the soft tissues surrounding the knee and the tendons of the quadriceps femoris. Under this
protocol we propose to develop additional numerical reconstruction, image analysis, and
display methods and test the applicability of fast-PC MRI and ultrasound to the study of
various normal and impaired joints (e.g., ankle, wrist, and knee). This development process
will require data from human subjects obtained from both static and dynamic MR and ultrasound
images.

This development is being guided by our philosophy that impaired joint function likely occurs
due to abnormal bone shape, abnormal musculoskeletal movements and forces, or both abnormal
bone shape and musculoskeletal movements and forces. Thus, our long-term vision is to
non-invasively quantify the in vivo 3D joint kinematics, bone shapes and tissue loads for
both the healthy impaired and normal volunteer populations, translate the methods and
findings into interventional research and ultimately into common clinical practice.

- INCLUSION CRITERIA ALL VOLUNTEERS:

All subjects must be between ages of 5 to unlimited. For subjects under 18 years of age,
they must be capable of giving assent with a parent or legal guardian providing informed
consent. For subjects ages 18 and above, they must be able to provide informed consent.
Subjects will either be healthy controls or healthy volunteers with a specific
musculoskeletal impairment, pathology, or variant.

EXCLUSION CRITERIA UNIMPAIRED VOLUNTEERS:

1. Any relevant medical problems (connective tissue problems, active arthritis, etc.)

2. Any clinical signs of an impairment in the joint being studied, such as mechanical
joint abnormalities including abnormal range of motion, muscle weakness, malaligment.

3. Any serious injury to the joint being studied, previous surgery on the joint being
studied or extreme pain at the joint being studied.

EXCLUSION CRITERIA ALL VOLUNTEERS:

All potential volunteers for the MR portion must complete the NIH Radiology screening
questionnaire. If any potential contraindication is found, either the volunteer s doctor
(with knowledge of the potential contraindication) or the radiology department at the NIH
will be contacted to determine if the potential contraindication would exclude you from the
specific MR scans being proposed. Subjects will be excluded if it is deemed that they have
a condition, which would preclude them from participating in an MRI study (e.g. paralyzed
hemidiaphragm, morbid obesity, claustrophobia etc.) or present unnecessary risks (e.g.
pregnancy, surgery of uncertain type, symptoms of pheochromocytoma or insulinoma, etc.).
Lastly, women who are pregnant will be excluded from participating in this study in order
to prevent any possible damage to the fetus.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 800-411-1222
?
mi
from
Bethesda, MD
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