CClinicalTrials.gg
CompletedNCT02011204Updated May 11, 2016

Study of Electrical Impedance Myography (EIM) in ALS

An observational study in Amyotrophic Lateral Sclerosis, Motor Neuron Disease and Charcot-Marie-Tooth Disease, sponsored by Skulpt, Inc.. Completed at 6 sites in United States. Open to participants aged 35 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-05-11.

Sponsored by Skulpt, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
106
Ages
35 Years to 80 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.
02

Conditions studied

  • Amyotrophic Lateral Sclerosis
  • Motor Neuron Disease
  • Charcot-Marie-Tooth Disease
  • Multiple Sclerosis
03

In context

Tooth Diseases

116 studies on the registry are indexed under Tooth Diseases; 14 are open to participants now.

This study's enrollment of 106 is close to the median of 106 across 33 observational studies indexed under Tooth Diseases.

Browse Tooth Diseases studies →

Lead sponsor

Skulpt, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

Eligibility criteria

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.*

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
106 participants (actual)
Patient registry
No

Groups and cohorts

  • 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)

  • Other Neurological Diseases

    People with a diagnosis of a disease that mimics ALS

    Device: Electrical impedance myography (EIM)

  • Healthy Controls

    Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS.

    Device: Electrical impedance myography (EIM)

Interventions

  • DeviceElectrical 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.

    Also known as: EIM1102 device

06

What researchers measure

Primary outcomes

  1. Discrimination between Groups

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

    Time frame: Duration of the Study (9 months for Group A, one visit for Groups B and C)

Secondary outcomes

  1. Tracking Progression

    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

    Time frame: Duration of Study, (9 months for Group A, one visit for Groups B and C)

  2. Correlation with Outcome Measures

    Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALSFRS-R, HHD and VC.

    Time frame: Duration of Study (9 months for Group A, one visit for Groups B and C)

07

Study locations

6 sites
  • St. Joseph's Hospital & Medical Center
    Phoenix, Arizona 85013, United States
  • University of Miami Miller School of Medicine
    Miami, Florida 33136, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Skulpt, Inc
    Boston, Massachusetts 02210, United States
  • SUNY Upstate Medical University
    Syracuse, New York 13210, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02011204
Lead sponsor
Skulpt, Inc.
Responsible party
Sponsor
First posted
Dec 13, 2013
Start date
Nov 2013
Primary completion
Mar 2016
Completion
Mar 2016
Last update
May 11, 2016

Study contacts

Jeremy Shefner, MD, PhD
principal investigator · State University of New York - Upstate Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion