Early Feasibility Study of the MyoRegulator® for Treatment of ALS

Launched by PATHMAKER NEUROSYSTEMS INC. · Dec 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the MyoRegulator® device, which is a new non-invasive treatment for people with amyotrophic lateral sclerosis (ALS), a condition that affects muscle control. The main goal of the study is to see if people with ALS can safely use this device without experiencing serious side effects. This is the first time the MyoRegulator® is being tested in ALS patients, and it has already shown promise in other conditions related to muscle issues.

To participate in this trial, individuals need to be 18 years or older and have a confirmed diagnosis of ALS. They should be willing to avoid certain medications and treatments during the study period. Participants will be closely monitored to ensure they can tolerate the treatment. It’s important for potential participants to know that those on certain types of ventilation or with specific medical conditions may not be eligible. This study is currently recruiting participants, and anyone interested should discuss it with their healthcare provider for more information.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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)
• Exclusion Criteria:
• • 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)