Study of Electrical Impedance Myography (EIM) in ALS

Multiple Sclerosis Clinical Trial

Official title:

Noninvasive Assessment of Neuromuscular Disease Using Electrical Impedance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011204
• Other study ID #: 2013P001505
• Status: Completed
• Phase: N/A
• First received: December 3, 2013
• Last updated: May 10, 2016
• Start date: November 2013
• Est. completion date: March 2016

Study information

• Verified date: May 2016
• Source: Skulpt, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

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.*

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Charcot-Marie-Tooth Disease
• Hereditary Sensory and Motor Neuropathy
• Motor Neuron Disease
• Multiple Sclerosis
• Nerve Compression Syndromes
• Sclerosis
• Tooth Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Skulpt, Inc	Boston	Massachusetts
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	St. Joseph's Hospital & Medical Center	Phoenix	Arizona
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Skulpt, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discrimination between Groups	Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes	Duration of the Study (9 months for Group A, one visit for Groups B and C)	No
Secondary	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	Duration of Study, (9 months for Group A, one visit for Groups B and C)	No
Secondary	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.	Duration of Study (9 months for Group A, one visit for Groups B and C)	No