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Clinical Trials/NCT02742298
NCT02742298
Completed
Not Applicable

Electrical Impedance Myography and Muscle Ultrasound: Longitudinal Measures in Pompe Disease

Duke University1 site in 1 country25 target enrollmentOctober 24, 2016
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:

  1. Determine the correlation between quantitative muscle ultrasound (QMUS), electrical impedance myography (EIM) and currently accepted measures of physical function.
  2. Determine the reliability of EIM measures performed in the home through use of a hand held device.
  3. Determine if QMUS and EIM can detect pre-clinical changes in Pompe disease.
Registry
clinicaltrials.gov
Start Date
October 24, 2016
End Date
July 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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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