Actively Recruiting

Age: 20Years - 90Years
All Genders
Healthy Volunteers
NCT05104710

Intermuscular Coherence as a Biomarker for ALS

Led by University of Chicago · Updated on 2026-02-09

650

Participants Needed

4

Research Sites

300 weeks

Total Duration

On this page

Sponsors

U

University of Chicago

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intermuscular Coherence as a Biomarker for ALS

Who Can Participate

Age: 20Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with arm or leg weakness, spastic gait, muscle wasting or twitching, difficulty swallowing or speaking, shortness of breath, hyperreflexia, pathological reflexes, or muscle denervation seen in prior EMG studies
  • Age between 20 and 90 years
  • Patients categorized as Possible, Probable, or Definite ALS by Awaji criteria without IMC measurement
Not Eligible

You will not qualify if you...

  • Previously classified as probable or definite ALS by Awaji criteria before study evaluation
  • Significant sensory loss in weak or spastic limbs
  • Significant musculoskeletal or neuropathic pain
  • Unable or unwilling to provide informed consent
  • Unable to perform study tasks
  • Currently taking baclofen, benzodiazepines, or sedatives
  • Known non-ALS cause for symptoms
  • History of neurological disorders such as stroke, neuropathy, or myopathy
  • Lack of cognitive ability or willingness to consent
  • Unclassified by Awaji category or diagnosed with an ALS mimic

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

University of California Center for Clinical Research

Irvine, California, United States, 92697

Active, Not Recruiting

2

University of Miami Miller School of Medicine

Miami, Florida, United States, 33136

Actively Recruiting

3

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

4

Washington University Medical Center

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

S

Serdar Aydin, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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