Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
PathMaker Neurosystems Inc.
Study ID
NCT06649955
Status
Recruiting
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Conditions

  • ALS - Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Multi-site direct current stimulation (DCS) — DEVICE
    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).

Study Details

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 Dates

Start date
Feb 10, 2025
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Active MyoRegulator Treatment Arm
    4 weeks of active MyoRegulator® device treatment three times per week then follow-up at 1 week, 1 month, 3 months, and optionally at 6 months following the end of treatment

Primary Outcome Measure

Feasibility of treating ALS patients using multi-site DCS [ Time Frame: On treatment day and at each follow-up visit out to 3 months post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Mia Hemme
[email protected]
617-667-3069
Seward Rutkove, M.D. (PRINCIPAL_INVESTIGATOR)
Courtney McIlduff, M.D., MMSc (SUB_INVESTIGATOR)

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By research site
Beth Israel Deaconess Medical Center· Boston, MA

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