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Status:

RECRUITING

EIM Via the Myolex mScan as an ALS Biomarker

Lead Sponsor:

Beth Israel Deaconess Medical Center

Collaborating Sponsors:

United States Department of Defense

Conditions:

Amyotrophic Lateral Sclerosis

Eligibility:

All Genders

18+ years

Brief Summary

Amyotrophic lateral sclerosis (ALS) has been traditionally considered incurable and untreatable. But starting in the 1990s with the introduction of Riluzole, therapies are being discovered and ultimat...

Detailed Description

Amyotrophic lateral sclerosis (ALS) has been traditionally considered incurable and untreatable. But starting in the 1990s with the introduction of Riluzole, therapies are being discovered and ultimat...

Eligibility Criteria

Inclusion

  • Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria
  • Capable of providing informed consent and complying with study procedures in the investigator's opinion
  • Time since ALS symptom onset ≤36 months
  • Vital Capacity of ≥50% of predicted capacity as measured by forced vital capacity
  • Must have a study partner for home visits
  • Access to the internet for data upload
  • Age 18 years or older

Exclusion

  • Clinically significant unstable medical condition (other than ALS) that would affect the participant's ability to participate, according to the investigator's judgment
  • Patient with pure upper motor neuron disease (PLS)
  • Known history of unstable psychiatric disease, cognitive impairment, dementia, or active substance abuse
  • Significant pitting edema (2+ or more) that would interfere with EIM measures
  • Active cancer or history of cancer treated with chemotherapy and/or radiation
  • BMI \>35

Key Trial Info

Start Date :

March 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 30 2026

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06491732

Start Date

March 1 2025

End Date

September 30 2026

Last Update

March 24 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215