RecruitingNot ApplicableNCT06649955

Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study


Sponsor

PathMaker Neurosystems Inc.

Enrollment

15 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Following completion of the ALS Early Feasibility Study of the MyoRegulator® device for treatment of ALS (NCT06165172), the CALM study will further assess the feasibility of the MyoRegulator® device to treat ALS in an expanded number of individuals with ALS. CALM will gather additional preliminary evidence of clinical safety and potential effectiveness in this patient population with a longer follow-up period and additional secondary endpoints in a single-arm study prior to commencing a larger sham-controlled pivotal trial.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment that uses magnetic stimulation delivered to the spinal cord through the skin (non-invasive) to try to reduce the overexcitability of motor neurons in people with ALS (amyotrophic lateral sclerosis, also known as Lou Gehrig's disease). Overactive motor neurons are thought to contribute to disease progression. **You may be eligible if...** - You are 18–80 years old - You have been diagnosed with ALS (sporadic or familial) within the past 3 years - Your ALS is at least 'possible' or 'probable' based on established diagnostic criteria - Your breathing capacity (slow vital capacity) is at least 50% of expected - Your nerve signal strength meets minimum criteria (median CMAP ≥1.5 mV) **You may NOT be eligible if...** - You are currently using certain medications such as botulinum toxin, intrathecal baclofen, digitalis, or morphine - You are enrolled in another ALS treatment trial - Your breathing or nerve function has declined too much Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMulti-site direct current stimulation (DCS)

The MyoRegulator® treatment is a non-invasive intervention that suppresses motor neuron hyperexcitability and activates protein degradation pathways through the use of multi-site direct current stimulation (multi-site DCS).


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT06649955


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