Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-27 @ 4:42 PM
Study NCT ID:
NCT02011204
Status:
COMPLETED
Last Update Posted:
2016-05-11
First Post:
2013-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Electrical Impedance Myography (EIM) in ALS
Sponsor:
Skulpt, Inc.
Organization:
Study Overview
Official Title:
Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance
Status:
COMPLETED
Status Verified Date:
2016-05
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:
This trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The trial is studying people with Amyotrophic Lateral Sclerosis (ALS), other neuromuscular diseases, and healthy volunteers to see if the EIM device can measure disease in muscle tissue.
Detailed Description:
This is a multicenter, 9-month study evaluating the effectiveness of electrical impedance myography (EIM) as a diagnostic and disease-tracking tool. In addition, the following will be studied:
1. Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes;
2. Track EIM progression over time and determine the best summary EIM measure that could serve as an endpoint in future clinical trials and individual patient care; and,
3. Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALS Functional Rating Scale, Revised (ALSFRS-R), Hand-held Dynamometry (HHD) and Vital Capacity (VC) measures.
1. Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes;
2. Track EIM progression over time and determine the best summary EIM measure that could serve as an endpoint in future clinical trials and individual patient care; and,
3. Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALS Functional Rating Scale, Revised (ALSFRS-R), Hand-held Dynamometry (HHD) and Vital Capacity (VC) measures.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: