Early Feasibility Study of the MyoRegulator® for Treatment of ALS

Completed · Not applicable

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT06165172

Run by

PathMaker Neurosystems Inc.

People needed

5

Starts

2023-06-21

Expected to finish

2024-08-31

Last updated by the study team

2025-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• A clinical diagnosis of ALS as confirmed by medical history
• Willing to forgo botulinum toxin, phenol or alcohol injections, intrathecal baclofen, digitalis, and morphine for the study duration
• Willing to refrain from participation in any other clinical trial for the duration of this study
• 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
• Cognitive function sufficient to understand the study and follow instructions (per interview with appropriate clinician)

You may not qualify if…

• Study participants who are on permanent assisted ventilation (PAV) defined as >22h of noninvasive or invasive ventilation a day for > 7 consecutive days.
• Implanted intrathecal pump
• Prior botulinum toxin injection(s) within 12 weeks of study enrollment
• Prior phenol or alcohol injections within 6 months of study enrollment
• Presence of potential risk factors for trans-spinal direct current stimulation:
• Damaged skin at the stimulation sites (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed, recent scar tissue, broken skin, etc.)
• 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)

Where it is running

• Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, United States

Full record on ClinicalTrials.gov

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