Clinical trial: Study of Electrical Impedance Myography (EIM) in ALS (NCT02011204)

Eligibility criteria:
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.*
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 35 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment