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Intermuscular Coherence as a Biomarker for ALS

University of Chicago · with National Institutes of Health (NIH), Massachusetts General Hospital · NCT05104710

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 20–90 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
650
US sites recruiting
3
Study start
March 31, 2021
Record last updated
February 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The specific aims of this study are to

  • 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.
  • Characterize IMC-βγ in neurotypical subjects by age, sex, race, and ethnicity.
  • 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.

Conditions: Amyotrophic Lateral Sclerosis

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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:
  • 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.

Recruiting US locations

  • University of Miami Miller School of Medicine

    Miami, FL 33136

    Site contact: Milagros Rodriguez · 305-243-6725 · mxr2872@med.miami.edu

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Sravan Mandepudi · 617-643-6036 · smandepudi@mgh.harvard.edu

  • Washington University Medical Center

    St Louis, MO 63110

    Site contact: Kelly McCoy-Gross · 314-273-8215 · kmccoygross@wustl.edu

Study contacts (from the official record)

  • Serdar Aydin, MD · (773)795-9908 · serdarmd@bsd.uchicago.edu
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Intermuscular Coherence as a Biomarker for ALS (NCT05104710) | Bored Studies