Trial record 2 of 5 for:    Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance

Study of Electrical Impedance Myography (EIM) in ALS

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by State University of New York - Upstate Medical University
Sponsor:
Collaborator:
Skulpt, Inc.
Information provided by (Responsible Party):
Jeremy Shefner, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT02011204
First received: December 3, 2013
Last updated: April 10, 2014
Last verified: April 2014

December 3, 2013
April 10, 2014
November 2013
April 2015   (final data collection date for primary outcome measure)
Discrimination between Groups [ Time Frame: Duration of the Study (9 months for Group A, one visit for Groups B and C) ] [ Designated as safety issue: No ]
Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes
Same as current
Complete list of historical versions of study NCT02011204 on ClinicalTrials.gov Archive Site
  • Tracking Progression [ Time Frame: Duration of Study, (9 months for Group A, one visit for Groups B and C) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALSFRS-R, HHD and VC.
Same as current
Not Provided
Not Provided
 
Study of Electrical Impedance Myography (EIM) in ALS
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

People with ALS People diagnosed with early ALS (possible, probable, or probable- laboratory supported 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.

  • Amyotrophic Lateral Sclerosis
  • Motor Neuron Disease
  • Charcot-Marie-Tooth Disease
  • Multiple Sclerosis
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
  • People with ALS
    People diagnosed with early ALS (possible, probable, or probable-laboratory supported ALS according to El Escorial criteria)
    Intervention: Device: Electrical impedance myography (EIM)
  • Other Neurological Diseases
    People with a diagnosis of a disease that mimics ALS
    Intervention: Device: Electrical impedance myography (EIM)
  • Healthy Controls
    Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS.
    Intervention: Device: Electrical impedance myography (EIM)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
April 2015
April 2015   (final data collection date for primary outcome measure)

Early ALS Inclusion Criteria:

  • Sporadic or familial ALS (as defined by revised El Escorial criteria)
  • Onset of weakness or spasticity due to ALS ≤ 24 months prior to the Screening/Baseline Visit.
  • Slow vital capacity (SVC) ≥60% of predicted for gender, height, and age

Early ALS Exclusion Criteria:

  • Diagnosis of definite 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.

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 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.*

Both
35 Years to 80 Years
Yes
Contact: Casey Brescia 617-643-7434 cbrescia@partners.org
United States
 
NCT02011204
2013P001505
No
Jeremy Shefner, State University of New York - Upstate Medical University
State University of New York - Upstate Medical University
Skulpt, Inc.
Principal Investigator: Jeremy Shefner, MD, PhD State University of New York - Upstate Medical University
State University of New York - Upstate Medical University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP