The ULTRA Study: Cross-Comparison of Ultrasound Systems

NCT ID: NCT02920619

Last Updated: 2018-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington D.C. Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Michael Harris-Love

Associate Director, CRC Human Performance Research Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Harris-Love, D.Sc.

Role: PRINCIPAL_INVESTIGATOR

Washington DC VA Medical Center

Locations

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Washington DC VA Medical Center

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

References

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Harris-Love MO, Seamon BA, Teixeira C, Ismail C. Ultrasound estimates of muscle quality in older adults: reliability and comparison of Photoshop and ImageJ for the grayscale analysis of muscle echogenicity. PeerJ. 2016 Feb 22;4:e1721. doi: 10.7717/peerj.1721. eCollection 2016.

Reference Type BACKGROUND
PMID: 26925339 (View on PubMed)

Other Identifiers

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MIRB01803

Identifier Type: -

Identifier Source: org_study_id

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