Using muscle activity measurements to improve ALS diagnosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• University of California Center for Clinical Research
  Irvine, California, United States Active not recruiting

Study contacts

• Principal investigator: Kourosh Rezania, MD — University of Chicago
• Study coordinator: Serdar Aydin, MD
• Email: serdarmd@bsd.uchicago.edu
• Phone: (773)795-9908

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.