Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance

Study Purpose:

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Healthy Volunteer, Healthy Volunteer with a Family History of ALS

Study Type:

Observational Study

Study Category:

Neals Affiliated, Diseases, Study Type, Study Status, Phase, Gender

Study Status:

Closed

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Jeremy Shefner, MD, PhD

Clinicaltrials.gov ID (11 digit #):

NCT02011204

Neals Affiliated?

Yes

Coordinating Center Contact Information

Mass General Hospital
Sara Vaughan / .(JavaScript must be enabled to view this email address) / 617-643-5374
.(JavaScript must be enabled to view this email address) 165 Cambridge Street
Boston, Massachusetts 02114 United States

Full 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.

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:

People with ALS: People diagnosed with early ALS (possible 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

Sampling Method: Non-Probability Sample

Ages Eligible for Study: 35 Years to 80 Years

Genders Eligible for Study: Both

Accepts healthy volunteers

Early ALS Inclusion Criteria:
• Sporadic or familial ALS (as defined by revised El Escorial criteria)
• Onset of weakness or spasticity due to ALS ≤ 18 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 probable, probable-laboratory supported, or 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.*

Study Sponsor:

Skulpt, Inc.

Participant Duration:

9 months

Estimated Enrollment:

120

Estimated Study Start Date:

10/31/2013

Estimated Study Completion Date:

02/29/2016

Posting Last Modified Date:

04/30/2016

Date Study Added to alsconsortium.org:

12/08/2013
  • More Information
    For more information, please visit https://clinicalt...CT02011204&rank=1
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    35

    Maximum Age:

    80

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?


  • Site Contact Information

    Wake Forest University Health Sciences
    Mozhdeh Marandi / .(JavaScript must be enabled to view this email address) / 336-713-8577
    Winston-Salem, North Carolina 27157
    United States

    SUNY Upstate Medical University
    Tanya Perry / .(JavaScript must be enabled to view this email address) / 315-464-4998
    Syracuse, New York 13210
    United States

    Skulpt, Inc.
    Jennifer Martino / .(JavaScript must be enabled to view this email address) / 888-382-8824
    Boston, Massachusetts 02210
    United States

    Massachusetts General Hospital
    Jenna Wells / .(JavaScript must be enabled to view this email address) / 617-505-9726
    Boston, Massachusetts 02114
    United States

    University of Miami, Miller School of Medicine
    Sumaira Hussain / .(JavaScript must be enabled to view this email address) / 305-243-8487
    Miami, Florida 33136
    United States

    Barrow Neurological Institute
    Gale Kittle / .(JavaScript must be enabled to view this email address) / 602-406-4792
    St. Joseph's Hospital & Medical Center
    Phoenix, Arizona 85013
    United States