MyoRegulator® for ALS

(ALSEFS Trial)

Overseen By Nader Yaghoubi, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: PathMaker Neurosystems Inc.

Must not be taking: Botulinum toxin, Phenol, Alcohol

Disqualifiers: Permanent assisted ventilation, Implanted pump, Epileptic seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the MyoRegulator® device is safe and effective for people with ALS, a disease affecting nerve cells in the brain and spinal cord. The MyoRegulator® is a non-invasive device that uses gentle electrical currents to potentially help manage symptoms. Participants must have ALS, refrain from using certain muscle-relaxing treatments during the trial, and understand study instructions. As an unphased trial, it offers participants the chance to contribute to pioneering research that could lead to new strategies for managing ALS symptoms.

Will I have to stop taking my current medications?

You will need to stop taking botulinum toxin, phenol or alcohol injections, intrathecal baclofen, digitalis, and morphine for the duration of the study.

What prior data suggests that the MyoRegulator® device is safe for treating ALS?

Research has shown that the MyoRegulator® device is generally safe and well-tolerated, being considered a low-risk treatment. In earlier studies, this non-surgical device treated muscle stiffness after a stroke and demonstrated positive safety results. No serious side effects emerged in these trials. The device operates by sending small, painless electrical currents through the skin to help control nerve activity. These findings suggest that the MyoRegulator® could be a safe option for people with ALS, as it has already been tested safely in other conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard ALS treatments that primarily focus on managing symptoms or slowing disease progression with medications, MyoRegulator® offers a novel approach by using a device-based intervention. Researchers are excited about MyoRegulator® because it utilizes a non-invasive method to potentially improve motor function by modulating neural pathways. This could provide a new avenue for treatment that is different from existing drug therapies, offering hope for enhanced quality of life for those living with ALS.

What evidence suggests that the MyoRegulator® device is effective for ALS?

Research shows that the MyoRegulator® device, which participants in this trial will receive, might help treat ALS by calming overactive nerve cells and slowing the disease's progression. This non-invasive tool sends gentle electrical currents to specific areas, potentially reducing nerve cell damage. Earlier studies have shown that this device can effectively manage muscle stiffness after a stroke, suggesting it could also be helpful for ALS. Although this is the first time researchers are testing it for ALS, the device's ability to target overactive nerve cells offers hope. Initial findings support its safety and ease of use, making it a promising non-drug option for managing ALS symptoms. ^{1 2 4 5 6}

Who Is on the Research Team?

J. Leon Morales-Quezada, M.D, Ph.D.

Principal Investigator

Spaulding Rehabilitation Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can understand and follow the study's instructions.

Willing to forgo pregnancy for the duration of the study

Willing and able to give informed consent or have informed consent provided for them by their legal guardian

Exclusion Criteria

Presence of potential risk factors for trans-spinal direct current stimulation: damaged skin at the stimulation sites, lack of sensory perception at the stimulation sites, presence of an electrically, magnetically, or mechanically activated implant (including cardiac pacemaker) or any other electrically sensitive support system with the exception of loop recorders, ferrous metal in the path of the current flow (jewelry must be removed during stimulation), past history of epileptic seizures or unexplained spells of loss of consciousness during the previous 36 months, any medical condition that would prevent the participant from being able to participate in the clinical outcome measures, pregnant females, as determined by a pregnancy test at enrollment (in females of child-bearing potential)

I have not had any botulinum toxin injections in the last 12 weeks.

I have been on a ventilator for more than 22 hours a day for over a week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active treatment with the MyoRegulator® device to assess safety and feasibility

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MyoRegulator®

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Active treatment with MyoRegulator® device

Who Is Running the Clinical Trial?

PathMaker Neurosystems Inc.

Lead Sponsor

Trials

5

Recruited

120+

Sean M. Healey & AMG Center for ALS

Collaborator

Trials

3

Recruited

90+

Spaulding Rehabilitation Hospital

Collaborator

Trials

143

Recruited

11,200+

Muscular Dystrophy Association

Collaborator

Trials

38

Recruited

60,800+

Sean M. Healey & AMG Center for ALS

Collaborator

Trials

1

Recruited

5+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06649955

Controlling Amyotrophic Lateral Sclerosis Motor Neuron ... The MyoRegulator® treatment is a non-invasive intervention that suppresses motor neuron hyperexcitability and activates protein degradation pathways through the ...

2. alsnewstoday.com alsnewstoday.com/news/us-trial-noninvasive-als-device-cleared-enroll-patients/

US trial of noninvasive ALS device gets green light to enroll ... The MyoRegulator device aims to reduce motor neuron damage and slow ALS progression by reducing hyperexcitability and activating certain ...

3. ctv.veeva.com ctv.veeva.com/study/early-feasibility-study-of-the-myoregulator-r-for-treatment-of-als

Early Feasibility Study of the MyoRegulator® for Treatment of ... The main objective of this study is to confirm that individuals with ALS can tolerate the study treatment regimen without any evidence of ...

4. neurologylive.com neurologylive.com/view/pathmaker-announces-first-in-human-trial-neurostimulation-device-myoregulator-als

PathMaker Announces First-In-Human Trial of ... In the study, patients with ALS will be asked to complete questionnaires, a physical examination, and undergo neurostimulation site visits 3 ...

5. ninds.nih.gov ninds.nih.gov/sites/default/files/documents/PathMaker_one-pager.Nov_2023_508C.pdf

Pathmaker Neurosystems Executive Summary The MyoRegulator® device is a safe, non-invasive, painless and cost-effective therapy for ALS. It represents the first non-pharmacological approach for treating ...

6. rally.massgeneralbrigham.org rally.massgeneralbrigham.org/study/als_myoregulator

Electrical Stimulation for ALS - Rally | Research Studies This study aims to investigate the feasibility and safety of using non-invasive electrical stimulation with the MyoRegulator neuromodulation device to treat ALS ...