RECRUITING

Intermuscular Coherence as a Biomarker for ALS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-03-31
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05104710

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.

Ages Eligible for Study:20 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * AIM 2: Subjects between 20 and 90 years of age.
  3. * AIM 3: Subjects will be selected from among Aim 1 patients who carry an Awaji (without IMC) category of Possible, Probable, or Definite ALS.
  1. * AIM 1:
  2. 1. Classified as probable or definite ALS by Awaji criteria prior to initial study evaluation
  3. 2. Have significant sensory loss in the weak or spastic limbs
  4. 3. Have significant musculoskeletal or neuropathic pain
  5. 4. Have an inability or are unwilling to provide informed consent
  6. 5. Are unable to perform the study-related task
  7. 6. Are taking baclofen or benzodiazepines
  8. 7. Have a known non-ALS cause for symptoms
  9. * AIM 2:
  10. 1. Have a history of neurological disorders such as stroke, neuropathy, or myopathy
  11. 2. Have significant pain or sensory loss
  12. 3. Are taking baclofen or sedatives such as benzodiazepines
  13. 4. Lack of cognitive ability or willingness to provide informed consent
  14. * AIM 3:
  15. 1. Were unclassified according to the Awaji category or had a defined ALS mimic
  16. 2. Are taking baclofen, sedatives or benzodiazepines.

Contacts and Locations

Study Contact

Serdar Aydin, MD
CONTACT
(773)795-9908
serdarmd@bsd.uchicago.edu

Principal Investigator

Kourosh Rezania, MD
PRINCIPAL_INVESTIGATOR
University of Chicago

Study Locations (Sites)

University of California Center for Clinical Research
Irvine, California, 92697
United States
University of Miami Miller School of Medicine
Miami, Florida, 33136
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Washington University Medical Center
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: University of Chicago

  • Kourosh Rezania, MD, PRINCIPAL_INVESTIGATOR, University of Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-31
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-03-31
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • ALS

Additional Relevant MeSH Terms

  • Amyotrophic Lateral Sclerosis