Intermuscular Coherence as a Biomarker for ALS
Recruiting now
Conditions studied: Amyotrophic Lateral Sclerosis
In brief
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.
Key facts
- Study ID
- NCT05104710
- Run by
- University of Chicago
- People needed
- 650
- Starts
- 2021-03-31
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-02-09
Who can join
Age: 20 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Miami Miller School of Medicine — Miami, Florida, United States (enrolling)
- Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
- Washington University Medical Center — St Louis, Missouri, United States (enrolling)
- University of California Center for Clinical Research — Irvine, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.