Intermuscular Coherence as a Biomarker for ALS
Intermuscular Coherence: A Biomarker for Early Diagnosis and Follow-up of ALS
University of Chicago
650 participants
Mar 31, 2021
OBSERVATIONAL
Conditions
Summary
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-βγ), when added to current diagnostic criteria (Awaji criteria), can differentiate ALS from mimic diseases more accurately and earlier than currently possible. 2. Characterize IMC-βγ in neurotypical subjects by age, sex, race, and ethnicity. 3. Follow a cohort of ALS patients longitudinally to determine if IMC-βγ changes with ALS disease progression and whether such changes correlate with functional and clinical scores, or survival.
Eligibility
Inclusion Criteria3
- 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 Criteria17
- AIM 1:
- Classified as probable or definite ALS by Awaji criteria prior to initial study evaluation
- Have significant sensory loss in the weak or spastic limbs
- Have significant musculoskeletal or neuropathic pain
- Have an inability or are unwilling to provide informed consent
- Are unable to perform the study-related task
- Are taking baclofen or benzodiazepines
- Have a known non-ALS cause for symptoms
- AIM 2:
- Have a history of neurological disorders such as stroke, neuropathy, or myopathy
- Have significant pain or sensory loss
- Are taking baclofen or sedatives such as benzodiazepines
- Lack of cognitive ability or willingness to provide informed consent
- AIM 3:
- Were unclassified according to the Awaji category or had a defined ALS mimic
- 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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Locations(4)
View Full Details on ClinicalTrials.gov
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NCT05104710