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

5 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

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

Principal Investigator

Spaulding Rehabilitation Hospital

Eligibility Criteria

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

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+