Study of Electrical Impedance Myography (EIM) in ALS



Status:Completed
Conditions:Neurology, Neurology, Neurology, Neurology, Neurology, Neurology, Dental, Multiple Sclerosis
Therapuetic Areas:Dental / Maxillofacial Surgery, Neurology, Other
Healthy:No
Age Range:35 - 80
Updated:5/12/2016
Start Date:November 2013
End Date:March 2016

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Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance

This trial is studying Electrical Impedance Myography (EIM) for measuring muscle health. The
trial is studying people with Amyotrophic Lateral Sclerosis (ALS), other neuromuscular
diseases, and healthy volunteers to see if the EIM device can measure disease in muscle
tissue.

This is a multicenter, 9-month study evaluating the effectiveness of electrical impedance
myography (EIM) as a diagnostic and disease-tracking tool. In addition, the following will
be studied:

1. Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal,
motor-predominant syndromes;

2. Track EIM progression over time and determine the best summary EIM measure that could
serve as an endpoint in future clinical trials and individual patient care; and,

3. Determine whether EIM progression is predictive of a combined outcome of survival and
progression as measured by ALS Functional Rating Scale, Revised (ALSFRS-R), Hand-held
Dynamometry (HHD) and Vital Capacity (VC) measures.

Early ALS Inclusion Criteria:

- Sporadic or familial ALS (as defined by revised El Escorial criteria)

- Onset of weakness or spasticity due to ALS ≤ 36 months prior to the
Screening/Baseline Visit.

- Slow vital capacity (SVC) ≥60% of predicted for gender, height, and age

Early ALS Exclusion Criteria:

- The presence of unstable psychiatric disease, cognitive impairment, or dementia that
would impair ability of the subject to provide informed consent, or a history of active
substance abuse within the prior year.

ALS Disease Mimics Inclusion Criteria:

- Diagnosis of one of the following:

a. Pure Lower Motor Neuron Disease (LMND) mimics: i. Multi-focal motor neuropathy ii.
Autoimmune motor neuropathy iii. Cervical or lumbosacral radiculopathies with weakness
involving more than one extremity or more than a single myotome if restricted to one
extremity.

iv. Multiple peripheral mononeuropathies with clinical weakness v. Charcot-Marie-Tooth
Disease vi. Any condition that produces generalized or localized weakness without
concomitant sensory symptoms, including myasthenia gravis or myopathy, that the evaluating
physician deems mimics ALS.

b. Pure Upper Motor Neuron Disease (UMND) mimics: i. Cervical myelopathy ii. Multiple
sclerosis iii. Hereditary spastic paraparesis

ALS Disease Mimics Exclusion Criteria:

- Diagnosis of possible, probable, probable-laboratory supported, or definite ALS

- Presence of positive family history of ALS.

- The presence of unstable psychiatric disease, cognitive impairment, or dementia that
would impair ability of the subject to provide informed consent, or a history of
active substance abuse within the prior year.

Healthy Volunteer Inclusion Criteria:

- Absence of a known neurological disorder.

Healthy Volunteer Exclusion Criteria:

- History of ALS, myopathy, neuropathy, ALS mimic disorder or other neurodegenerative
disease.

- Presence of positive family history of ALS.

- The presence of unstable psychiatric disease, cognitive impairment, or dementia that
would impair ability of the subject to provide informed consent, or a history of
active substance abuse within the prior year.

*Please note that this is not a complete listing on all eligibility criteria.*
We found this trial at
6
sites
1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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Boston, Massachusetts 02210
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Boston, MA
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Phoenix, AZ
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750 East Adams Street
Syracuse, New York 13210
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Syracuse, NY
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1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Winston-Salem, NC
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