Intermuscular Coherence as a Biomarker for ALS

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Intermuscular Coherence as a Biomarker for ALS

Condition
Amyotrophic Lateral Sclerosis
Intervention / Treatment

-

Contacts and Locations

Irvine

University of California Center for Clinical Research, Irvine, California, United States, 92697

Miami

University of Miami Miller School of Medicine, Miami, Florida, United States, 33136

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Saint Louis

Washington University Medical Center, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

20 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Chicago,

Kourosh Rezania, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

2025-12-31