Clinical trial NCT00620698: Electrical Impedance Myography as an Outcome Measure in Amyotrophic Lateral Sclerosis Clinical Trials
Official title: Electrical Impedance Myography as an Outcome Measure in ALS Clinical Trials
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Keywords: amyotrophic lateral sclerosis
motor neuron disease
outcome measure
biomarker
impedance
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: ALS Association
First posted: 2008-02-21
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with amyotrophic lateral sclerosis (ALS)

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.


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

Primary outcomes:
measure: Electrical Impedance Myography
timeFrame: 6 months
Secondary outcomes:
measure: ALS Functional Rating Scale
timeFrame: 6 months
measure: Handheld Dynamometry
timeFrame: 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Syracuse
country: United States
facility: Upstate Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Seward B Rutkove, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Upstate Medical Center
name: Jeremy M Shefner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.