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| 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 |
| 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 |
Patients with amyotrophic lateral sclerosis (ALS)
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Seward B. Rutkove, MD | 617-667-8130 | srutkove@bidmc.harvard.edu |
| 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 | |
| Principal Investigator: | Seward B Rutkove, MD | Beth Israel Deaconess Medical Center |
| Principal Investigator: | Jeremy M Shefner, MD, PhD | Upstate Medical Center |
More Information
| 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 |
|
amyotrophic lateral sclerosis motor neuron disease outcome measure biomarker impedance |
|
Pathologic Processes Neuromuscular Diseases Spinal Cord Diseases Amyotrophic Lateral Sclerosis Nervous System Diseases |
Central Nervous System Diseases Sclerosis Neurodegenerative Diseases Motor Neuron Disease |