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RECRUITING
NCT06649955
NA

Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study

Sponsor: PathMaker Neurosystems Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2025-02-10

Completion Date

2026-11

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

DEVICE

Multi-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