MRI Study of Musculoskeletal Function

This study is currently recruiting participants.
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00051857
First received: January 16, 2003
Last updated: March 14, 2014
Last verified: December 2013
  Purpose

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.


Condition
Healthy

Study Type: Observational
Official Title: Virtual Functional Anatomy (VFA)

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 500
Study Start Date: January 2003
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA ALL VOLUNTEERS:

They must be between ages of 5 to unlimited who are capable of giving informed consent.

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, malalignment.
  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 volunteer will be excluded from the MR portion of the protocol if he/she has a any of the following contraindication to MR imaging:

  1. Aneurysm clip
  2. Implanted neural stimulator
  3. Implanted cardiac pacemaker or autodefibrillator
  4. Cochlear implant
  5. Ocular foreign body (e.g. metal shavings)
  6. Insulin pump

In addition, 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00051857

Contacts
Contact: Sara F Sadeghi (301) 496-4733 sara.sadeghi@nih.gov
Contact: Frances Gavelli, Ph.D. (301) 402-6056 gavellif@cc.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Frances Gavelli, Ph.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00051857     History of Changes
Other Study ID Numbers: 030060, 03-CC-0060
Study First Received: January 16, 2003
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Magnetic Resonance Imaging
Muscle
Bone
Dynamics
Visualization

ClinicalTrials.gov processed this record on April 17, 2014