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NCT00620698 · ClinicalTrials.gov registry record
Electrical Impedance Myography as an Outcome Measure in Amyotrophic Lateral Sclerosis Clinical Trials
A clinical trial, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- 89
- Enrollment target
NCT00620698: Completed study, sponsored by Beth Israel Deaconess Medical Center.
NCT00620698 is a clinical trial that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 89 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00620698 has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- 89 participants
- Enrollment target
Study 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.
Primary Outcome
The main outcome measure was the coefficient of variation (CoV) in the rate of the decline for each measure over time. The CoV was calculated by dividing the standard deviation in the rate of decline across the group of subjects and dividing that by the mean rate of decline for the cohort. This approach was taken for each of the measures being evaluated (ALS Functional Rating Scale-Revised, Handheld dynamometry, Electrical impedance myography). The lower the CoV in the rate of decline, the more
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2007-05 |
| Est. Completion | 2012-03 |
What the finished NCT00620698 record still lists
NCT00620698 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 89 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT00620698 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00620698 about?
NCT00620698 is a clinical study titled "Electrical Impedance Myography as an Outcome Measure in Amyotrophic Lateral Sclerosis Clinical Trials". 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 outcom...
What is the current status of trial NCT00620698?
This trial is currently completed. The enrollment target is 89 participants. The study started on 2007-05. Estimated completion is 2012-03.
Who is sponsoring clinical trial NCT00620698?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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