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The ULTRA Study: Cross-Comparison of Ultrasound Systems

Sponsor
Washington D.C. Veterans Affairs Medical Center (U.S. Fed)
Overall Status
Unknown status
CT.gov ID
NCT02920619
Collaborator
(none)
30
Enrollment
1
Location
27
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

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 Phase
  • 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
Anticipated 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 :
Sep 1, 2016
Anticipated Primary Completion Date :
Sep 1, 2018
Anticipated Study Completion Date :
Dec 1, 2018

Outcome Measures

Primary Outcome Measures

  1. Echogenicity [1 day]

    Echogenicity values (i.e., image brightness) obtained from the ultrasound scans (units: grayscale levels, 0-255)

Secondary Outcome Measures

  1. Muscle thickness [1 day]

    Morphometry values (units: cm) obtained from the ultrasound scans using digital calipers.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Washington DC VA Medical Center Washington District of Columbia United States 20422

Sponsors and Collaborators

  • Washington D.C. Veterans Affairs Medical Center

Investigators

  • Principal Investigator: Michael Harris-Love, D.Sc., Washington DC VA Medical Center

Study Documents (Full-Text)

None provided.

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
Other Study ID Numbers:
  • MIRB01803
First Posted:
Sep 30, 2016
Last Update Posted:
May 17, 2018
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Michael Harris-Love, Associate Director, CRC Human Performance Research Unit, Washington D.C. Veterans Affairs Medical Center
ultrasound
muscle

Study Results

No Results Posted as of May 17, 2018