← Back to Search

Neuromodulation Device

Intervention for Amyotrophic Lateral Sclerosis (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks following the last treatment

Awards & highlights

ALSEFS Trial 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.Check my eligibility

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.See study design

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.

ALSEFS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been diagnosed with ALS.

Select...

I am willing to stop certain medications like botulinum toxin and morphine for the study.

ALSEFS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 weeks following the last treatment

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Improvement in Activities of Daily Living

Improvement in Functionality

Improvement in Quality of Life

ALSEFS 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

PathMaker Neurosystems Inc.Lead Sponsor

3 Previous Clinical Trials

146 Total Patients Enrolled

Spaulding Rehabilitation HospitalOTHER

135 Previous Clinical Trials

11,050 Total Patients Enrolled

Muscular Dystrophy AssociationOTHER

36 Previous Clinical Trials

60,426 Total Patients Enrolled

10 Trials studying Amyotrophic Lateral Sclerosis

16,494 Patients Enrolled for Amyotrophic Lateral Sclerosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period open for this investigation?

"Indeed, clinicaltrials.gov indicates that this experiment is being conducted and recruiting patients. Initially posted on June 21st 2021, the trial's most recent edit was made December 6th 2021. The research team seeks 5 volunteers from a single medical centre to participate in the study."

Answered by AI

How many participants are being accepted to participate in this research?

"Affirmative. According to the information stored on clinicaltrials.gov, this medical study is actively searching for participants and commenced recruitment on June 21st 2023 with its last update occurring December 6th 2023. This research requires 5 individuals from 1 particular location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Early Feasibility Study of the MyoRegulator® for Treatment of ALS

2023. "Early Feasibility Study of the MyoRegulator® for Treatment of ALS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06165172.

All > Lou Gehrigs Disease > Als