Early Feasibility Study of the MyoRegulator® for Treatment of ALS

NCT06165172 | Completed FDA Device

• 1 other identifier: PMN-004
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosis; neuromodulation; motor neuron hyperexcitability suppression; non-invasive

Outcome Measures

Primary Outcomes (2)

• Safety as measured by number of patients with any device-related serious adverse event

  Safety will be evaluated by recording the frequency, severity, and duration of any adverse events reported by study participants or observed by physical examination during or following treatment and throughout the study duration.

  Up to 4 weeks following the last treatment

• Tolerability as measured by patient's ability to complete the treatments

  Treatment tolerability will be evaluated by assessing the ease of delivering treatment, the tolerability of study participants to the treatment, and the compliance of study participants with the study schedule and evaluations.

  Up to 4 weeks following the last treatment

Secondary Outcomes (3)

• Improvement in Functionality

  Up to 4 weeks following the last treatment

• Improvement in Activities of Daily Living

  Up to 4 weeks following the last treatment

• Improvement in Quality of Life

  Up to 4 weeks following the last treatment

Study Arms (1)

Intervention

EXPERIMENTAL

Active treatment with MyoRegulator® device

Device: MyoRegulator®

Interventions

MyoRegulator® DEVICE

Study participants will receive treatment using the MyoRegulator® device 3 times a week for 2 x 30 minutes per session. The first week of treatment will be followed by a 1-week rest period with no treatments. Treatment sessions will then resume for 4 consecutive weeks, 3 times per week. A follow-up visit will be scheduled 4 weeks after the last treatment session.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• PathMaker Neurosystems Inc.: lead
• Spaulding Rehabilitation Hospital: collaborator
• Sean M. Healey & AMG Center for ALS: collaborator
• Muscular Dystrophy Association: collaborator

Study Sites (1)

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• J. Leon Morales-Quezada, M.D, Ph.D.

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 11, 2023
• Study Start: June 21, 2023
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)