Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-01-28 @ 2:37 PM
Study NCT ID:
NCT03633318
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing Muscle Impedance Parameters With Electrical Impedance Myography
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Application of Electrical Impedance Myography (EIM) to Establish Muscle Impedance Parameters as a Potential Biomarker of Inclusion Body Myositis (IBM)
Status:
COMPLETED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary aim of this study is to assess the changes in the impedance parameters of muscles in inclusion body myositis (IBM) through electrical impedance myography (EIM), an emerging non-invasive electrodiagnostic technology. Muscle impedance parameters can potentially serve as an objective biomarker reflecting disease progression and severity.
Detailed Description:
In this pilot study, the electrical impedance myography (EIM) parameters of individuals with inclusion body myositis (IBM) will be compared with age and sex matched normal data. Along with EIM parameters, clinical outcome measures will be obtained to understand how EIM data correlates with these parameters. A focused study to assess muscle health in IBM patients through EIM is essential to gather further insight into the potential application of this technology as a disease biomarker. Additionally, this investigation will provide critical data for the design of a subsequent biomarker validation study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: