Pompe Disease QMUS and EIM
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|ClinicalTrials.gov Identifier: NCT02742298|
Recruitment Status : Active, not recruiting
First Posted : April 19, 2016
Last Update Posted : March 29, 2019
- Determine the correlation between quantitative muscle ultrasound (QMUS), electrical impedance myography (EIM) and currently accepted measures of physical function.
- Determine the reliability of EIM measures performed in the home through use of a hand held device.
- Determine if QMUS and EIM can detect pre-clinical changes in Pompe disease.
|Condition or disease||Intervention/treatment||Phase|
|Pompe Disease||Device: Muscle ultrasound Other: Electrical Impedance Myography||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Device Feasibility|
|Official Title:||Electrical Impedance Myography and Muscle Ultrasound: Longitudinal Measures in Pompe Disease|
|Actual Study Start Date :||October 24, 2016|
|Estimated Primary Completion Date :||April 20, 2020|
|Estimated Study Completion Date :||April 20, 2020|
All patients will undergo serial quantitative muscle ultrasound.
Device: Muscle ultrasound
Ultrasound images of limb muscles will be collected.
All patients will undergo serial electrical impedance myography measures.
Other: Electrical Impedance Myography
A painless current passes through the skin and surface electrodes are used to record the impedance through muscle.
- Percent change in muscle ultrasound echointensity as compared to baseline [ Time Frame: Baseline, 1-2 years ]
- Percent change in muscle electrical impedance myography as compared to baseline [ Time Frame: Baseline, 1-2 years ]
- Inter-rater reliability of muscle ultrasound and electrical impedance myography measures [ Time Frame: 1-2 years ]
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): NCT02742298
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Lisa D Hobson-Webb, MD||Duke University|