NCT05104710Recruiting
Intermuscular Coherence as a Biomarker for ALS
Intermuscular Coherence: A Biomarker for Early Diagnosis and Follow-up of ALS
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 650 (estimated)
- First submitted
- 21 Oct 2021
- Start date
- 31 Mar 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Chicago
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT05104710
What you commit to
- Study type: Observational
- Planned participants: 650
- From 31 Mar 2021 to the primary completion date, 31 Dec 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 20 years to 90 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of California Center for Clinical Research Coordinator of this site? Confirm its status | Irvine | United States | Active, not recruiting |
| University of Miami Miller School of Medicine Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Washington University Medical Center Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.