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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 2009
First Received: February 9, 2008   Last Updated: August 28, 2009   History of Changes
Sponsor: Beth Israel Deaconess Medical Center
Collaborator: 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

Study Type: Observational
Study Design: Cohort, 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:

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
Study First Received: February 9, 2008
Last Updated: August 28, 2009
ClinicalTrials.gov Identifier: NCT00620698     History of Changes
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:
Pathologic Processes
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Central Nervous System Diseases
Sclerosis
Neurodegenerative Diseases
Motor Neuron Disease

ClinicalTrials.gov processed this record on February 08, 2010