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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Beth Israel Deaconess Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
ALS Association
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00620698
First received: February 9, 2008
Last updated: April 1, 2011
Last verified: April 2011
  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:

Estimated Enrollment: 120
Study Start Date: May 2007
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: March 2009 (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 B. Rutkove, MD, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00620698     History of Changes
Other Study ID Numbers: EIMALS
Study First Received: February 9, 2008
Last Updated: April 1, 2011
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
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014