Study of Electrical Impedance Myography (EIM) in ALS

NCT02011204 | Completed

• 1 other identifier: 2013P001505
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 6

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.

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Charcot-Marie-Tooth Disease; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (2)

• Tracking Progression

  Duration of Study, (9 months for Group A, one visit for Groups B and C)

• Correlation with Outcome Measures

  Duration of Study (9 months for Group A, one visit for Groups B and C)

Study Arms (3)

People with ALS

People diagnosed with early ALS (possible, probable, probable-laboratory supported or definite ALS according to El Escorial criteria) Intervention: Electrical Impedance Myography (EIM).

Device: Electrical impedance myography (EIM)

Other Neurological Diseases

People with a diagnosis of a disease that mimics ALS

Device: Electrical impedance myography (EIM)

Healthy Controls

Healthy Volunteers that do not have ALS or another neurological disease that mimics ALS.

Device: Electrical impedance myography (EIM)

Interventions

Electrical impedance myography (EIM) DEVICE

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.

Also known as: EIM1102 device

Healthy Controls; Other Neurological Diseases; People with ALS

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- 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.
• \- 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
• 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.
• \- Absence of a known neurological disorder.
• 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.\*

Sponsors & Collaborators

• Skulpt, Inc.: lead

Study Sites (6)

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Skulpt, Inc

Boston, Massachusetts, 02210, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Charcot-Marie-Tooth Disease; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Polyneuropathies; Peripheral Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jeremy Shefner, MD, PhD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 13, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 11, 2016

Record last verified: 2016-05

Locations

US (6)