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Trial record 7 of 1254 for:    veterans affairs medical center

The ULTRA Study: Cross-Comparison of Ultrasound Systems (ULTRA)

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ClinicalTrials.gov Identifier: NCT02920619
Recruitment Status : Recruiting
First Posted : September 30, 2016
Last Update Posted : September 30, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to develop computational methods for cross-comparison of muscle composition measurements in three laboratory ultrasound systems.

Condition or disease Intervention/treatment
Healthy Device: Ultrasound

Detailed Description:
The purpose of this study is to develop computational methods for cross-comparison of muscle composition measurements in three laboratory ultrasound systems. We propose a cross-sectional study to obtain ultrasound images of selected muscles in Veteran participants. These data will be used to develop conversion models for each system. Evaluation of neuromuscular symptoms such as muscle weakness and fatigue is crucial to improving quality of life among Veterans. These symptoms may be related to progressive changes in muscle tissue composition, including increased intramuscular fat and atrophy. Quantitative musculoskeletal ultrasound is a diagnostic imaging application used to characterize muscle tissue composition. Despite its non-invasiveness and relative low cost, quantitative musculoskeletal ultrasound has not been widely adopted by the medical community due in part to technical barriers that impede generalization of measurements across ultrasound systems. Unfortunately, few techniques have been proposed to reliably compare system measurements. Development of new cross-comparison methods could expand quantitative musculoskeletal ultrasound applications and improve neuromuscular symptoms diagnosis.

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The ULTRA Study: Cross-Comparison of Muscle Composition Measures in Multiple Ultrasound Systems
Study Start Date : September 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Device: Ultrasound
    Imaging of the rectus femoris, lower-trapezius, brachioradialis, tibialis anterior, middle deltoid, and pectoralis major will be conducted in Veteran participants during a single visit to the Washington D.C. Veterans Affairs Medical Center. Imaging will be conducted by investigators experienced with quantitative ultrasound using diagnostic musculoskeletal B-mode ultrasound with a 10 Mhz linear transducer.

Outcome Measures

Primary Outcome Measures :
  1. Echogenicity [ Time Frame: 1 day ]
    Echogenicity values (i.e., image brightness) obtained from the ultrasound scans (units: grayscale levels, 0-255)


Secondary Outcome Measures :
  1. Muscle thickness [ Time Frame: 1 day ]
    Morphometry values (units: cm) obtained from the ultrasound scans using digital calipers.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Thirty adult Veterans (20-85 years) will be recruited for the study from the DC VAMC.
Criteria

Inclusion Criteria:

  • Male or female Veteran who receives medical care at the Washington DC VA Medical Center
  • Ages 20-85

Exclusion Criteria:

  • Limb amputation (upper or lower extremity)
  • Lower extremity joint replacement
  • Severe cognitive impairment
  • Edema
  • Inability to read, speak, or understand English
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920619


Contacts
Contact: Tomas Gonzales, MA 202-745-8000 ext 55852 tomas.gonzales@va.gov
Contact: Brian Hoover, MS 202-745-8000 ext 55826 brian.hoover@va.gov

Locations
United States, District of Columbia
Washington DC VA Medical Center Recruiting
Washington, District of Columbia, United States, 20422
Contact: Tomas Gonzales, MA    202-745-8000 ext 55852    tomas.gonzales@va.gov   
Contact: Brian Hoover, MS    202-745-8000 ext 55826    brian.hoover@va.gov   
Principal Investigator: Michael Harris-Love, DSc         
Sponsors and Collaborators
Washington D.C. Veterans Affairs Medical Center
Investigators
Principal Investigator: Michael Harris-Love, D.Sc. Washington DC VA Medical Center
More Information

Publications:
Responsible Party: Michael Harris-Love, Associate Director, CRC Human Performance Research Unit, Washington D.C. Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02920619     History of Changes
Other Study ID Numbers: MIRB01803
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: September 30, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michael Harris-Love, Washington D.C. Veterans Affairs Medical Center:
ultrasound
muscle