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Intermuscular Coherence as a Biomarker for ALS
Intermuscular Coherence: A Biomarker for Early Diagnosis and Follow-up of ALS
Who can join
Ages 20 to 90 · All sexes · Healthy volunteers welcome
Full eligibility criteria
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.
About the study
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.
Sponsor: University of Chicago · Participants: 650 · Started: Mar 31, 2021
Contact the study team
- Serdar Aydin, MD · Phone: (773)795-9908
Official record on ClinicalTrials.gov — NCT05104710
Locations in the U.S.
| Florida | University of Miami Miller School of Medicine, Miami |
| Massachusetts | Massachusetts General Hospital, Boston |
| Missouri | Washington University Medical Center, St Louis |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.