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

NCT ID: NCT00620698

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 89 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2012-03-31

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ALS patients

Patients with clinically established amyotrophic lateral sclerosis

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ALS Association

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Seward Rutkove

Principal Invesigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seward B Rutkove, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Jeremy M Shefner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Upstate Medical Center

Locations

University of Miami Miller School of Medicine

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Johns Hopkins

Baltimore, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Upstate Medical Center

Syracuse, New York, United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

University of Virginia Medical Center

Charlottesville, Virginia, United States

Countries

United States

References

Rutkove SB, Zhang H, Schoenfeld DA, Raynor EM, Shefner JM, Cudkowicz ME, Chin AB, Aaron R, Shiffman CA. Electrical impedance myography to assess outcome in amyotrophic lateral sclerosis clinical trials. Clin Neurophysiol. 2007 Nov;118(11):2413-8. doi: 10.1016/j.clinph.2007.08.004. Epub 2007 Sep 25.

Reference Type: BACKGROUND

PMID: 17897874 (View on PubMed)

Other Identifiers

EIMALS

Identifier Type: -

Identifier Source: org_study_id