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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
  Purpose

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.


Condition Intervention
Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Charcot-Marie-Tooth Disease
Multiple Sclerosis
Device: Electrical impedance myography (EIM)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: November 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
People with ALS
People diagnosed with early ALS (possible, probable, or probable-laboratory supported ALS according to El Escorial criteria)
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

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.
  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.*

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011204

Contacts
Contact: Casey Brescia 617-643-7434 cbrescia@partners.org

Locations
United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Sumaira Hussain    305-243-8487    sumaira.hussain@med.miami.edu   
Principal Investigator: Michael Benatar, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Theodore Peng    617-643-2522    tpeng1@partners.org   
Principal Investigator: William David, MD, PhD         
Skulpt, Inc Recruiting
Boston, Massachusetts, United States, 02210
Contact: Jennifer Martino    888-382-8824    jennifer@skulpt.me   
Principal Investigator: Erik Ensrud, MD         
United States, New York
SUNY Upstate Medical University Recruiting
Syracuse, New York, United States, 13210
Contact: Tanya Perry    315-464-4998    perryt@upstate.edu   
Principal Investigator: Jeremy Shefner, MD, PhD         
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Mozhdeh Marandi    336-713-8577    mmarandi@wakehealth.edu   
Principal Investigator: James Carress, MD         
Sponsors and Collaborators
State University of New York - Upstate Medical University
Skulpt, Inc.
Investigators
Principal Investigator: Jeremy Shefner, MD, PhD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: Jeremy Shefner, Principal Investigator, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT02011204     History of Changes
Other Study ID Numbers: 2013P001505
Study First Received: December 3, 2013
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Charcot-Marie-Tooth Disease
Motor Neuron Disease
Tooth Diseases
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Central Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Immune System Diseases
Metabolic Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Peripheral Nervous System Diseases
Spinal Cord Diseases
Stomatognathic Diseases
Amyotrophic Lateral Sclerosis
Hereditary Sensory and Motor Neuropathy
Multiple Sclerosis
Nerve Compression Syndromes
Sclerosis
Congenital Abnormalities
Nervous System Malformations
Pathologic Processes
Polyneuropathies
Proteostasis Deficiencies
TDP-43 Proteinopathies

ClinicalTrials.gov processed this record on November 25, 2014