Intermuscular Coherence as a Biomarker for ALS

Part of paid clinical trials in Irvine, California.

Sponsor
University of Chicago
Study ID
NCT05104710
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 90 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Mar 31, 2021
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
650 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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

Locations (4)

FacilityCityStateZIPSite coordinators
University of California Center for Clinical ResearchIrvineCalifornia92697-
University of Miami Miller School of MedicineMiamiFlorida33136
Milagros Rodriguez
[email protected]
305-243-6725
Nathan Carrbery, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Sravan Mandepudi
[email protected]
617-643-6036
Doreen A Ho, MD (PRINCIPAL_INVESTIGATOR)
Washington University Medical CenterSt LouisMissouri63110
Kelly McCoy-Gross
[email protected]
314-273-8215
Bethany Gannon
[email protected]
(314) 273-1686
Sean S Smith, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of California Center for Clinical Research· Irvine, CAUniversity of Miami Miller School of Medicine· Miami, FLMassachusetts General Hospital· Boston, MAWashington University Medical Center· St Louis, MO

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