Menu
Recruiting NCT05104710

Intermuscular Coherence as a Biomarker for ALS

— Observational Amyotrophic Lateral Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Amyotrophic Lateral Sclerosis. Basic parameters: 20 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Detailed description

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disease caused by neuronal death in the motor system, both in the brain and spinal cord. It results in progressive weakness throughout the body, and typically leads to respiratory failure 3-5 years after symptom onset. Therapy initiation and drug development are hindered, in part, by the lack of objective disease markers.

This is a multi-center trial to validate a potential biomarker for ALS, known as intermuscular coherence (IMC-βγ). IMC measures the correlation in the activity of two muscles during a simple motor task. In a preliminary study we found that patients with ALS have lower IMC than do control subjects. Because measuring IMC is quick, non-invasive, painless, and only requires equipment readily available in standard clinical neurophysiology labs, if validated it would be an important biomarker for ALS.

Primary outcome measures

  • Change in the sensitivity for diagnosing ALS when a measure of intermuscular coherence is added to the Awaji criteria. [Time frame: 5 years]
Secondary outcome measures (2)
  • Time to diagnosis of ALS [Time frame: 5 years]
  • Rate of ALS disease progression [Time frame: 5 years]

Eligibility criteria

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:
  • 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
  • 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
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 4 centers
  • University of California Center for Clinical Research — Irvine
  • University of Miami Miller School of Medicine — Miami
  • Massachusetts General Hospital — Boston
  • Washington University Medical Center — St Louis

Publications

  • Issa NP, Frank S, Roos RP, Soliven B, Towle VL, Rezania K. Intermuscular coherence in amyotrophic lateral sclerosis: A preliminary assessment. Muscle Nerve. 2017 Jun;55(6):862-868. doi: 10.1002/mus.25426. Epub 2017 Feb 3. PMID 27699797

Identifiers

NCT: NCT05104710 · IRB20-1478 · 1R01NS116262-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗