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

Status: Recruiting
Location: See all (4) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 90
Healthy Volunteers: t
View:

• 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.

Locations
United States
California
University of California Center for Clinical Research
ACTIVE_NOT_RECRUITING
Irvine
Florida
University of Miami Miller School of Medicine
RECRUITING
Miami
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Missouri
Washington University Medical Center
RECRUITING
St Louis
Contact Information
Primary
Serdar Aydin, MD
serdarmd@bsd.uchicago.edu
(773)795-9908
Time Frame
Start Date: 2021-03-31
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 650
Treatments
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.
Sponsors
Collaborators: Washington University School of Medicine, University of California, Irvine, Massachusetts General Hospital, National Institutes of Health (NIH), National Institute of Neurological Disorders and Stroke (NINDS)
Leads: University of Chicago

This content was sourced from clinicaltrials.gov