Study Purpose:
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 Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Seward B Rutkove, MD, Beth Israel Deaconess Medical Center, Jeremy M Shefner, MD, PhD, Upstate Medical Center
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02446 United States
Full Study Summary:
Study Sponsor:
Beth Israel Deaconess Medical Center
Estimated Enrollment:
89
Estimated Study Start Date:
11 / 02 / 2016
Estimated Study Completion Date:
03 / 01 / 2012
Posting Last Modified Date:
09 / 25 / 2014
Date Study Added to neals.org:
02 / 21 / 2008
Minimum Age:
18 Years
Maximum Age:
85 Years
Inclusion Criteria:- Definite or probably ALS by El Escorial criteria
- Muscle strength of at 3.5 in one limb
Exclusion Criteria:
- Forced vital capacity of less than 70%
- Atypical forms of motor neuron disease (monomelic amyotrophy, primary lateral sclerosis)
- Pacemaker
University of Miami Miller School of Medicine
Miami, Florida
33136
United States
Emory University
Atlanta, Georgia
United States
Johns Hopkins
Baltimore, Maryland
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts
02446
United States
Massachusetts General Hospital
Boston, Massachusetts
United States
Upstate Medical Center
Syracuse, New York
United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina
27157
United States
University of Virginia Medical Center
Charlottesville, Virginia
22908
United States