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Electrical Impedance Myography as an Outcome Measure in Amyotrophic Lateral Sclerosis Clinical Trials - NCT00620698-(Clinical Trial 203645)



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City:  Syracuse
State:  
NY
Zip Code:
Conditions: Amyotrophic Lateral Sclerosis
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 summary:
Criteria: 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
Study is available at: Upstate Medical Center
Syracuse, NY
United States

Primary Contact:
Mary Lou Watson
Email: watsonma@upstate.edu

Secondary Contact:
Seward B. Rutkove, MD
Email: srutkove@bidmc.harvard.edu
Phone: 617-667-8130
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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