NCT06491732 EIM Via the Myolex mScan as an ALS Biomarker
| NCT ID | NCT06491732 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-03-01 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 ultimately approved for slowing disease progression. Many pharmaceutical companies continue to seek new therapeutic approaches. One critical aspect of all clinical trials is the need track to progression sensitively to identify the impact of therapy. Tools to track ALS progression must be convenient, objective, require minimal training, be easily standardized, cost-efficient, and have the potential to be applied effectively at home. There has been a push to identify accurate, objective biomarkers of ALS progression. In this study, the investigators propose to use Electrical impedance myography (EIM) to evaluate the progression of the disease. Work has shown that the EIM 50 kilohertz (kHz) phase value from one or more muscles, followed sequentially, can serve as an effective overall biomarker for assessing the rate of ALS progression for a single person.
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 ≥40% of predicted capacity as measured by forced vital capacity or slow 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
Contact & Investigator
Seward Rutkove, MD
PRINCIPAL INVESTIGATOR
Beth Israel Deaconess Medical Center
Frequently Asked Questions
Who can join the NCT06491732 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06491732 currently recruiting?
Yes, NCT06491732 is actively recruiting participants. Contact the research team at gcenci@bidmc.harvard.edu for enrollment information.
Where is the NCT06491732 trial being conducted?
This trial is being conducted at Phoenix, United States, Boston, United States, Boston, United States, Ann Arbor, United States and 2 additional locations.
Who is sponsoring the NCT06491732 clinical trial?
NCT06491732 is sponsored by Beth Israel Deaconess Medical Center. The principal investigator is Seward Rutkove, MD at Beth Israel Deaconess Medical Center. The trial plans to enroll 80 participants.
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