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โ† Trials
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Intermuscular Coherence as a Biomarker for ALS

Recruitingn/aAges 20 Years - 90 YearsAllUniversity of Chicago
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In plain words

What the trial is, and whether it could suit you

The specific aims of this study are to: 1. Determine if a painless and quick measurement of muscle activity using surface electrodes can help with the diagnosis of ALS. Specifically, we ask if a measure of intermuscular coherence (IMC-ฮฒฮณ), when added to current diagnostic criteria (Awaji criteria), can differentiate ALS from mimic diseases more accurately and earlier than currently possible. 2. Characterize IMC-ฮฒฮณ in neurotypical subjects by age, sex, race, and ethnicity. 3. Follow a cohort of ALS patients longitudinally to determine if IMC-ฮฒฮณ changes with ALS disease progression and whether such changes correlate with functional and clinical scores, or survival.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * AIM 1: Patients with arm or leg weakness, spastic gait, muscle wasting and/or fasciculations (muscle twitching), dysphagia (difficulty swallowing), dysarthria (difficulty speaking), shortness of breath, hyperreflexia or pathological reflexes, or findings of muscle denervation in previous needle electromyography (EMG) studies. * AIM 2: Subjects between 20 and 90 years of age. * AIM 3: Subjects will be selected from among Aim 1 patients who carry an Awaji (without IMC) category of Possible, Probable, or Definite ALS. Exclusion Criteria: * AIM 1: 1. Classified as probable or definite ALS by Awaji criteria prior to initial study evaluation 2. Have significant sensory loss in the weak or spastic limbs 3. Have significant musculoskeletal or neuropathic pain 4. Have an inability or are unwilling to provide informed consent 5. Are unable to perform the study-related task 6. Are taking baclofen or benzodiazepines 7. Have a known non-ALS cause for symptoms * AIM 2: 1. Have a history of neurological disorders such as stroke, neuropathy, or myopathy 2. Have significant pain or sensory loss 3. Are taking baclofen or sedatives such as benzodiazepines 4. Lack of cognitive ability or willingness to provide informed consent * AIM 3: 1. Were unclassified according to the Awaji category or had a defined ALS mimic 2. Are taking baclofen, sedatives or benzodiazepines. NOTE: Participation in a therapeutic clinical trial is NOT an exclusion criterion since this study would not interfere with any potential interventions.
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What it tests

  • Not listed
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Where

4 sites
University of California Center for Clinical Research
Irvine, United States
University of Miami Miller School of Medicine
Miami, United States
Massachusetts General Hospital
Boston, United States
Washington University Medical Center
St Louis, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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