Recruiting

Biomarker for ALS

Sponsor:

University of Chicago

Code:

NCT05104710

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Amyotrophic Lateral Sclerosis

Study ID

NCT05104710

Start date

Mar 31, 2021

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

650 participants

Anticipated

Interventions and Outcome Measures

Arms

AIM 1

Hypothesis: IMC-βγ can help to differentiate between ALS and mimic diseases at initial presentation.

Patients who present to a neuromuscular clinic with symptoms that might be from ALS but for whom a diagnosis is not yet known, will be studied. Measurements of intermuscular coherence will be made using surface electrodes. A standard neurological examination and questionnaire about ALS symptoms will be completed. No interventions will be made. A patient's final diagnosis will be determined using standard-of-care testing. Six months after initial IMC measurement, a determination will be made whether the IMC predicted the diagnosis of ALS.

AIM 2

Hypothesis: Characterization of demographic-specific distributions will improve the specificity of IMC-βγ for ALS.

To optimize cutoff values for abnormal IMC, IMC-βγ will be measured in neurotypical controls across a range of age, race, ethnicity, and sexes.

AIM 3

Hypothesis: IMC-βγ will decrease with disease progression.

Because IMC-βγ measures functional input from motor neurons in the brain, it should decrease as these neurons are lost. IMC will be measured sequentially about every 3 months in patients with ALS, and will be compared to measures of clinical progression.

Primary outcome measure

  • Change in the sensitivity for diagnosing ALS when a measure of intermuscular coherence is added to the Awaji criteria. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Serdar Aydin, MD

(773)795-9908serdarmd@bsd.uchicago.edu

Locations

University of Miami Miller School of Medicine

Recruiting

Miami, Florida, United States, 33136

Contacts

Milagros Rodriguez

305-243-6725mxr2872@med.miami.edu

Principal Investigator:

Nathan Carrbery, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Sravan Mandepudi

617-643-6036smandepudi@mgh.harvard.edu

Principal Investigator:

Doreen A Ho, MD

Washington University Medical Center

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Kelly McCoy-Gross

314-273-8215kmccoygross@wustl.edu

Bethany Gannon

(314) 273-1686bgannon@wustl.edu

Principal Investigator:

Sean S Smith, MD

More Information

Sponsor

University of Chicago

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • ALS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-02-09.