Study of Electrical Impedance Myography (EIM) in ALS

Completed

• Conditions: Charcot-Marie-Tooth Disease; Motor Neuron Disease; Multiple Sclerosis; Amyotrophic Lateral Sclerosis
• Interventions: Device: Electrical impedance myography (EIM)

• Registration Number: NCT02011204
• Lead Sponsor: Skulpt, Inc.

Brief 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.

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-13
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
People with ALS	Electrical impedance myography (EIM)	People diagnosed with early ALS (possible, probable, probable-laboratory supported or definite ALS according to El Escorial criteria) Intervention: Electrical Impedance Myography (EIM).
Other Neurological Diseases	Electrical impedance myography (EIM)	People with a diagnosis of a disease that mimics ALS
Healthy Controls	Electrical impedance myography (EIM)	Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS.

Primary Outcome Measures

Name	Time	Method
Discrimination between Groups	Duration of the Study (9 months for Group A, one visit for Groups B and C)	Determine EIM device's ability to discriminate between ALS and "look-alike" non-fatal, motor-predominant syndromes

Secondary Outcome Measures

Name	Time	Method
Tracking Progression	Duration of Study, (9 months for Group A, one visit for Groups B and C)	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	Duration of Study (9 months for Group A, one visit for Groups B and C)	Determine whether EIM progression is predictive of a combined outcome of survival and progression as measured by ALSFRS-R, HHD and VC.

Trial Locations

Locations (6)

St. Joseph's Hospital & Medical Center; 🇺🇸 Phoenix, Arizona, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States

Skulpt, Inc; 🇺🇸 Boston, Massachusetts, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States