Electrical Impedance Myography as an Outcome Measure in Amyotrophic Lateral Sclerosis Clinical Trials

This study has been completed.
Sponsor:
Collaborator:
ALS Association
Information provided by (Responsible Party):
Seward Rutkove, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00620698
First received: February 9, 2008
Last updated: September 13, 2014
Last verified: September 2014
  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.


Condition
Amyotrophic Lateral Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Electrical Impedance Myography as an Outcome Measure in ALS Clinical Trials

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Electrical Impedance Myography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.


Secondary Outcome Measures:
  • ALS Functional Rating Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.

  • Handheld Dynamometry [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 sensitive it is to identifying a potential treatment effect, since it suggests gives a measure of homogeneity of the rate of decline across the population as well as the overall rate of decline. The smaller the standard deviation across the group and the larger the mean rate of decline across the group, the lower the CoV and the fewer number of subjects needed for a potential clinical trial using that outcome measure.


Enrollment: 89
Study Start Date: May 2007
Study Completion Date: March 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
ALS patients
Patients with clinically established amyotrophic lateral sclerosis

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with amyotrophic lateral sclerosis (ALS)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620698

Locations
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02446
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, New York
Upstate Medical Center
Syracuse, New York, United States
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
ALS Association
Investigators
Principal Investigator: Seward B Rutkove, MD Beth Israel Deaconess Medical Center
Principal Investigator: Jeremy M Shefner, MD, PhD Upstate Medical Center
  More Information

Publications:
Responsible Party: Seward Rutkove, Principal Invesigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00620698     History of Changes
Other Study ID Numbers: EIMALS
Study First Received: February 9, 2008
Results First Received: July 18, 2014
Last Updated: September 13, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
amyotrophic lateral sclerosis
motor neuron disease
outcome measure
biomarker
impedance

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Sclerosis
Central Nervous System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Pathologic Processes
Proteostasis Deficiencies
Spinal Cord Diseases
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on October 23, 2014