Electrical Impedance Myography as an Outcome Measure in Amyotrophic Lateral Sclerosis Clinical Trials
Completed
Conditions studied: Amyotrophic Lateral Sclerosis
In brief
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.
Key facts
- Study ID
- NCT00620698
- Run by
- Beth Israel Deaconess Medical Center
- People needed
- 89
- Starts
- 2007-05-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2014-09-25
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Definite or probably ALS by El Escorial criteria
- Muscle strength of at 3.5 in one limb
You may not qualify if…
- Forced vital capacity of less than 70%
- Atypical forms of motor neuron disease (monomelic amyotrophy, primary lateral sclerosis)
- Pacemaker
Where it is running
- University of Miami Miller School of Medicine — Miami, Florida, United States
- Emory University — Atlanta, Georgia, United States
- Johns Hopkins — Baltimore, Maryland, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, 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, United States
- University of Virginia Medical Center — Charlottesville, Virginia, United States
Full record on ClinicalTrials.gov
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