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NCT02742298 Clinical Trial

Pompe Disease QMUS and EIM

Pompe Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02742298
Other study ID # Pro00072199
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 24, 2016
Est. completion date July 31, 2020

Study information
Verified date February 2020
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date July 31, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Genetically confirmed diagnosis of Pompe disease.

Exclusion Criteria:

- Age <18 years

- Inability to provide informed consent.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Muscle ultrasound
Ultrasound images of limb muscles will be collected.
Other:
• Electrical Impedance Myography
A painless current passes through the skin and surface electrodes are used to record the impedance through muscle.

Locations
Country Name City State
United States Duke University Medical Center Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Duke University Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change in muscle ultrasound echointensity as compared to baseline Baseline, 1-2 years
Primary Percent change in muscle electrical impedance myography as compared to baseline Baseline, 1-2 years
Secondary Inter-rater reliability of muscle ultrasound and electrical impedance myography measures 1-2 years
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