This trial is active, not recruiting.

Condition amyotrophic lateral sclerosis
Sponsor Beth Israel Deaconess Medical Center
Collaborator ALS Association
Start date May 2007
End date March 2009
Trial size 120 participants
Trial identifier NCT00620698, EIMALS


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients with clinically established amyotrophic lateral sclerosis

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Electrical Impedance Myography as an Outcome Measure in ALS Clinical Trials
Principal investigator Seward B Rutkove, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center.