Study of Electrical Impedance Myography (EIM) in ALS
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ClinicalTrials.gov Identifier: NCT02011204 |
Recruitment Status :
Completed
First Posted : December 13, 2013
Last Update Posted : May 11, 2016
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Condition or disease | Intervention/treatment |
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Amyotrophic Lateral Sclerosis Motor Neuron Disease Charcot-Marie-Tooth Disease Multiple Sclerosis | Device: Electrical impedance myography (EIM) |
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:
- Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes;
- 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,
- 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.
Study Type : | Observational |
Actual Enrollment : | 106 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | March 2016 |
Actual Study Completion Date : | March 2016 |

Group/Cohort | Intervention/treatment |
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People with ALS
People diagnosed with early ALS (possible, probable, probable-laboratory supported or definite ALS according to El Escorial criteria) Intervention: Electrical Impedance Myography (EIM). |
Device: Electrical impedance myography (EIM)
In EIM, high-frequency alternating electrical current is applied to localized areas of muscle via surface electrodes and the consequent surface voltage patterns analyzed. EIM is very sensitive to the compositional and structural elements of muscle. Data from both human subjects and animal disease models, including ALS, spinal muscular atrophy (SMA), and Duchenne muscular dystrophy (DMD), show that EIM may be sensitive to a variety of pathological states. It is anticipated that EIM will thus likely be able to assist in quantifying the severity of the disease affecting various muscle groups as well as in measuring changes in the disease over time. Other Name: EIM1102 device |
Other Neurological Diseases
People with a diagnosis of a disease that mimics ALS
|
Device: Electrical impedance myography (EIM)
In EIM, high-frequency alternating electrical current is applied to localized areas of muscle via surface electrodes and the consequent surface voltage patterns analyzed. EIM is very sensitive to the compositional and structural elements of muscle. Data from both human subjects and animal disease models, including ALS, spinal muscular atrophy (SMA), and Duchenne muscular dystrophy (DMD), show that EIM may be sensitive to a variety of pathological states. It is anticipated that EIM will thus likely be able to assist in quantifying the severity of the disease affecting various muscle groups as well as in measuring changes in the disease over time. Other Name: EIM1102 device |
Healthy Controls
Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS.
|
Device: Electrical impedance myography (EIM)
In EIM, high-frequency alternating electrical current is applied to localized areas of muscle via surface electrodes and the consequent surface voltage patterns analyzed. EIM is very sensitive to the compositional and structural elements of muscle. Data from both human subjects and animal disease models, including ALS, spinal muscular atrophy (SMA), and Duchenne muscular dystrophy (DMD), show that EIM may be sensitive to a variety of pathological states. It is anticipated that EIM will thus likely be able to assist in quantifying the severity of the disease affecting various muscle groups as well as in measuring changes in the disease over time. Other Name: EIM1102 device |
- Discrimination between Groups [ Time Frame: Duration of the Study (9 months for Group A, one visit for Groups B and C) ]Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes
- Tracking Progression [ Time Frame: Duration of Study, (9 months for Group A, one visit for Groups B and C) ]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
- Correlation with Outcome Measures [ Time Frame: Duration of Study (9 months for Group A, one visit for Groups B and C) ]Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALSFRS-R, HHD and VC.

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Ages Eligible for Study: | 35 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
People with ALS People diagnosed with early ALS (possible, probable, probable- laboratory supported or definite ALS according to El Escorial criteria)
Other Neurological Diseases People with a diagnosis of a disease that mimics ALS
Healthy Controls Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS.
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.*

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02011204
United States, Arizona | |
St. Joseph's Hospital & Medical Center | |
Phoenix, Arizona, United States, 85013 | |
United States, Florida | |
University of Miami Miller School of Medicine | |
Miami, Florida, United States, 33136 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Skulpt, Inc | |
Boston, Massachusetts, United States, 02210 | |
United States, New York | |
SUNY Upstate Medical University | |
Syracuse, New York, United States, 13210 | |
United States, North Carolina | |
Wake Forest University Health Sciences | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Jeremy Shefner, MD, PhD | State University of New York - Upstate Medical University |
Responsible Party: | Skulpt, Inc. |
ClinicalTrials.gov Identifier: | NCT02011204 |
Other Study ID Numbers: |
2013P001505 |
First Posted: | December 13, 2013 Key Record Dates |
Last Update Posted: | May 11, 2016 |
Last Verified: | May 2016 |
Tooth Diseases Multiple Sclerosis Motor Neuron Disease Amyotrophic Lateral Sclerosis Charcot-Marie-Tooth Disease Nerve Compression Syndromes Hereditary Sensory and Motor Neuropathy Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |
Neurodegenerative Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Stomatognathic Diseases Nervous System Malformations Heredodegenerative Disorders, Nervous System Polyneuropathies Peripheral Nervous System Diseases Congenital Abnormalities Genetic Diseases, Inborn |