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Early Feasibility Study of the MyoRegulator® for Treatment of ALS

NCT06165172 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-03-25

No results posted yet for this study

Summary

This is a single-center, single-arm, open-label study aiming to assess the safety and feasibility of the MyoRegulator® device when used to treat individuals with amyotrophic lateral sclerosis (ALS). This study is the first use of the MyoRegulator® device to treat individuals with ALS. The main objective of this study is to confirm that individuals with ALS can tolerate the study treatment regimen without any evidence of serious adverse events related to the use of the device.

The MyoRegulator® device is a non-significant risk (NSR) investigational non-invasive neuromodulation device that uses multi-site direct current (multi-site DCS) stimulation. It has been used in two completed clinical trials evaluating its efficacy to treat post-stroke muscle spasticity and is currently being evaluated in a third trial in this post-stroke population.

Conditions

Interventions

DEVICE

MyoRegulator®

Study participants will receive treatment using the MyoRegulator® device 3 times a week for 2 x 30 minutes per session. The first week of treatment will be followed by a 1-week rest period with no treatments. Treatment sessions will then resume for 4 consecutive weeks, 3 times per week. A follow-up visit will be scheduled 4 weeks after the last treatment session.

Sponsors & Collaborators

  • Spaulding Rehabilitation Hospital

    collaborator OTHER

  • Sean M. Healey & AMG Center for ALS

    collaborator OTHER

  • Muscular Dystrophy Association

    collaborator OTHER

  • PathMaker Neurosystems Inc.

    lead INDUSTRY

Principal Investigators

  • J. Leon Morales-Quezada, M.D, Ph.D. · Spaulding Rehabilitation Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-21
Primary Completion
2024-07-31
Completion
2024-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06165172 on ClinicalTrials.gov