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Neuromodulation Device

MyoRegulator® for ALS (ALSEFS Trial)

N/A
Recruiting
Led By J. Leon Morales-Quezada, M.D, Ph.D.
Research Sponsored by PathMaker Neurosystems Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
A clinical diagnosis of ALS as confirmed by medical history
Must not have
Study participants who are on permanent assisted ventilation (PAV) defined as >22h of noninvasive or invasive ventilation a day for > 7 consecutive days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks following the last treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new device to treat ALS w/o invasive procedures. The main objective is to ensure it is safe & feasible w/o serious adverse events.

Who is the study for?
This trial is for adults over 18 with ALS who can consent to treatment. They must not be pregnant, use certain muscle relaxants or painkillers, have skin damage where the device will be used, metal implants in the current's path, a history of seizures or loss of consciousness in the last 3 years, or require permanent assisted ventilation.
What is being tested?
The MyoRegulator® device is being tested for safety and feasibility in treating ALS. It's an open-label study meaning everyone knows they're getting this non-invasive neuromodulation device that has been previously studied for post-stroke muscle spasticity.
What are the potential side effects?
Since it's a feasibility study focusing on safety, specific side effects aren't listed but may include discomfort at stimulation sites or potential unknown risks associated with new medical devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with ALS.
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I am willing to stop certain medications like botulinum toxin and morphine for the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been on a ventilator for more than 22 hours a day for over a week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks following the last treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks following the last treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety as measured by number of patients with any device-related serious adverse event
Tolerability as measured by patient's ability to complete the treatments
Secondary study objectives
Improvement in Activities of Daily Living
Improvement in Functionality
Improvement in Quality of Life

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
Active treatment with MyoRegulator® device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MyoRegulator®
2018
N/A
~50

Find a Location

Who is running the clinical trial?

PathMaker Neurosystems Inc.Lead Sponsor
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~0 spots leftby Dec 2024
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