Electrical Impedance Myography as an Outcome Measure in Amyotrophic Lateral Sclerosis Clinical Trials - NCT00620698-27157 (Clinical Trial 203647)
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| City: |
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Winston-Salem |
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State:
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NC |
| Zip Code: |
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27157 |
| Conditions: |
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Amyotrophic Lateral Sclerosis |
| Purpose: |
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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.
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| Study summary: |
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| Criteria: |
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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 |
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| Study is available at: |
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Wake Forest University Baptist Medical Center
Winston-Salem, NC 27157
United States
Primary Contact:
Theresa J Crews
Email: tjcrews@wfubmc.edu
Phone: 336-716-2323
Secondary Contact:
Seward B. Rutkove, MD
Email: srutkove@bidmc.harvard.edu
Phone: 617-667-8130 |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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March 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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