Using muscle activity measurements to improve ALS diagnosis

Intermuscular Coherence: A Biomarker for Early Diagnosis and Follow-up of ALS

This study is testing if a new way of measuring muscle activity can help doctors diagnose ALS more accurately and track how the disease changes over time.

Quick facts

• Study type: Observational
• Enrollment: 650 (estimated)
• Ages: 20 Years to 90 Years
• Sex: All
• Sponsor: University of Chicago (other)
• Locations: 4 sites (Irvine, California and 3 other locations)
• Trial ID: NCT05104710 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the effectiveness of intermuscular coherence (IMC-βγ) as a biomarker for diagnosing amyotrophic lateral sclerosis (ALS). By measuring muscle activity through surface electrodes, the study seeks to determine if IMC-βγ can enhance the accuracy of ALS diagnosis compared to current criteria. Additionally, it will characterize IMC-βγ in neurotypical individuals and follow ALS patients over time to assess changes in IMC-βγ related to disease progression and clinical outcomes. The study is multi-centered, involving several prominent medical institutions.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 20 to 90 with symptoms suggestive of ALS, such as muscle weakness or spastic gait, who have not yet been classified as probable or definite ALS.

Not a fit: Patients who have already been classified as probable or definite ALS or have significant sensory loss or other non-ALS causes for their symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier and more accurate diagnosis of ALS, improving patient outcomes and facilitating timely treatment.

How similar studies have performed: While this approach is innovative, preliminary studies have indicated that measuring IMC may differentiate ALS from other conditions, suggesting potential for success.

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.

Where this trial is running

Irvine, California and 3 other locations

• University of California Center for Clinical Research — Irvine, California, United States (ACTIVE_NOT_RECRUITING)
• University of Miami Miller School of Medicine — Miami, Florida, United States (RECRUITING)
• Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
• Washington University Medical Center — St Louis, Missouri, United States (RECRUITING)

Study contacts

• Principal investigator: Kourosh Rezania, MD — University of Chicago
• Study coordinator: Serdar Aydin, MD

Conditions: Amyotrophic Lateral Sclerosis, ALS