CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 89 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00620698
NCT00620698N/ACompleted

Electrical Impedance Myography as an Outcome Measure in ALS Clinical Trials

Beth Israel Deaconess Medical Center·observational·Posted Feb 21, 2008·Updated Sep 25, 2014

In Brief

An observational study for Amyotrophic Lateral Sclerosis. Completed, enrolled 89 participants across 8 sites.

Detailed Summary

Trials evaluating new therapies for stopping or slowing the progression of ALS depend critically upon the use of outcome measures to assess whether a potential treatment is effective. The more effective an outcome measure, the fewer patients need to be enrolled and the shorter the trial. Many outcome measures have been used over the years, including strength assessments, breathing tests, functional status surveys, and nerve testing, but all are far from ideal. A new method, called electrical impedance myography (EIM) appears to be especially promising in that it provides very consistent data from one testing session to the next, is sensitive to the muscle deterioration that occurs in ALS, and is entirely painless and non-invasive. In this study, investigators from multiple institutions plan to compare several different outcome measures, including EIM, in approximately 120 ALS patients, with each patient being followed for a period of one year. All of these measures will be compared to one another and an assessment of their ability to detect disease progression made. Our goal will be to determine whether EIM can serve as a valuable new outcome measure, ultimately leading to substantially faster, more effective ALS trials requiring fewer patients.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsALS Association

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 21, 2008
Enrollment StartMay 1, 2007
Primary CompletionMar 1, 2011
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.4 years ago