Muscle Signal Measurement to Help Diagnose and Track ALS
Tests a painless muscle activity measure to help diagnose and follow amyotrophic lateral sclerosis.
Plain-language title generated from the registry record
Registry title: Intermuscular Coherence as a Biomarker for ALS
Key facts
- Where
- Boston, Irvine, Miami, and St Louis, United StatesSee the 4 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 90 years old?
Source: NCT05104710, who can take part
Where in United States
- Massachusetts General HospitalBoston, United StatesTaking people
- University of California Center for Clinical ResearchIrvine, United StatesNo longer taking part
- University of Miami Miller School of MedicineMiami, United StatesTaking people
- Washington University Medical CenterSt Louis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Chicago
- Trial code
- NCT05104710
- Record updated
- 9 February 2026
- Original description
The specific aims of this study are to:Read full original descriptionShow less
Intermuscular Coherence: A Biomarker for Early Diagnosis and Follow-up of ALS
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.
Inclusion: 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: 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.