NCT02742298
Completed
Not Applicable
Electrical Impedance Myography and Muscle Ultrasound: Longitudinal Measures in Pompe Disease
ConditionsPompe Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pompe Disease
- Sponsor
- Duke University
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Percent change in muscle ultrasound echointensity as compared to baseline
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Study Objectives:
- 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Genetically confirmed diagnosis of Pompe disease.
Exclusion Criteria
- •Age \<18 years
- •Inability to provide informed consent.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Inter-rater reliability of muscle ultrasound and electrical impedance myography measures(1-2 years)
Study Sites (1)
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