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

This study is currently recruiting participants.
Verified by Beth Israel Deaconess Medical Center, August 2008

Sponsors and Collaborators: Beth Israel Deaconess Medical Center
ALS Association
Information provided by: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00620698
  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

Genetics Home Reference related topics:   amyotrophic lateral sclerosis   

MedlinePlus related topics:   Amyotrophic Lateral Sclerosis   

U.S. FDA Resources

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

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

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   120
Study Start Date:   May 2007
Estimated Study Completion Date:   December 2010
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

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

Contacts
Contact: Seward B. Rutkove, MD     617-667-8130     srutkove@bidmc.harvard.edu    

Locations
United States, Florida
University of Miami Miller School of Medicine     Recruiting
      Miami, Florida, United States, 33136
      Contact: Julie Steele     305-243-7526     JSteele@med.miami.edu    
      Principal Investigator: Khema Sharma, MD            
United States, Georgia
Emory University     Recruiting
      Atlanta, Georgia, United States
      Contact: Sharon Usher     404-727-0942     Sharon.Usher@emoryhealthcare.org    
      Principal Investigator: Michael Benatar, MD            
United States, Maryland
Johns Hopkins     Recruiting
      Baltimore, Maryland, United States
      Contact: Lora Clawson         lclawson@jhmi.edu    
      Principal Investigator: Nicholas Maragakis, MD            
United States, Massachusetts
Beth Israel Deaconess Medical Center     Recruiting
      Boston, Massachusetts, United States, 02446
      Contact: Connie Lin, BA     617-667-3053     clin2@bidmc.harvard.edu    
      Principal Investigator: Seward B Rutkove, MD            
Massachusetts General Hospital     Recruiting
      Boston, Massachusetts, United States
      Contact: Namita Goyal, MD         nagoyal@partners.rog    
      Principal Investigator: William David, MD, PhD            
United States, New York
Upstate Medical Center     Recruiting
      Syracuse, New York, United States
      Contact: Mary Lou Watson         watsonma@upstate.edu    
      Principal Investigator: Jeremy M Shefner            
United States, North Carolina
Wake Forest University Baptist Medical Center     Recruiting
      Winston-Salem, North Carolina, United States, 27157
      Contact: Theresa J Crews     336-716-2323     tjcrews@wfubmc.edu    
      Principal Investigator: James Caress, MD            
United States, Virginia
University of Virginia Medical Center     Recruiting
      Charlottesville, Virginia, United States, 22908
      Contact: Cindy Fischer     434-243-2867     CRB3Y@hscmail.mcc.virginia.edu    
      Principal Investigator: Ted Burns, MD            

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:   Beth Israel Deaconess Medical Center ( Seward B. Rutkove, MD, Principal Investigator )
Study ID Numbers:   EIMALS
First Received:   February 9, 2008
Last Updated:   August 15, 2008
ClinicalTrials.gov Identifier:   NCT00620698
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  

Study placed in the following topic categories:
Amyotrophic lateral sclerosis
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Central Nervous System Diseases
Lou Gehrig's disease
Sclerosis
Degenerative motor system disease
Neurodegenerative Diseases
Motor neuron disease
Motor Neuron Disease

Additional relevant MeSH terms:
Pathologic Processes
Nervous System Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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