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Search / Trial NCT06491732

EIM Via the Myolex mScan as an ALS Biomarker

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Jul 1, 2024

Trial Information

Current as of July 21, 2025

Recruiting

Keywords

Amyotrophic Lateral Sclerosis Electrical Impedance Myography Biomarker

ClinConnect Summary

This clinical trial is exploring a new way to monitor the progression of Amyotrophic Lateral Sclerosis (ALS), a serious condition that affects nerve cells and leads to muscle weakness. Researchers are using a technique called Electrical Impedance Myography (EIM), which measures electrical signals in muscles, to see if it can serve as an effective tool to track how ALS changes over time. This method is designed to be easy to use and could even allow patients to participate from home, making it more convenient for everyone involved.

To join this study, participants need to be diagnosed with ALS within the last three years and have a good level of lung function. They should also have a study partner who can assist with home visits and must have access to the internet to share data. It's important for potential participants to be in stable health and not have conditions that could interfere with the study. If you or someone you know is interested, this trial could help in understanding ALS better and contribute to finding new treatments.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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

About Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center (BIDMC) is a leading academic medical center located in Boston, Massachusetts, affiliated with Harvard Medical School. Renowned for its commitment to cutting-edge research and innovation in healthcare, BIDMC fosters a collaborative environment that integrates patient care, education, and scientific investigation. The center actively sponsors clinical trials across a variety of disciplines, aiming to advance medical knowledge and improve patient outcomes. With a focus on translational medicine, BIDMC's research initiatives engage multidisciplinary teams to address complex health challenges and translate findings into effective therapeutic strategies.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Seward Rutkove, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Masumeh Hatami, MD

Study Director

Beth Israel Deaconess Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported