Clinical Trial Alert: Medical Device Feasibility Study for People with ALS

Researchers at PathMaker Neurosystems Inc. are seeking individuals living with amyotrophic lateral sclerosis (ALS) to participate in a feasibility study to evaluate the safety and tolerability of an investigational neuromodulation device, the MyoRegulator®. This device is a non-invasive neuromodulation device that delivers electrical stimulation to the spinal cord and targeted limbs. It is being evaluated for the ability to suppress motor neuron hyperexcitability (the tendency of spinal cord motor neurons to become overactive) in people with ALS, which could potentially help counter the motor dysfunction and decreased survival caused by the disease.

This trial is a single-center, single-arm, non-blinded clinical trial. This means that all participants at one study site will be treated with the medical device, with no placebo control. The total trial duration for each participant will be 10 weeks, which includes 16 visits at the following frequency: three treatment visits during week 1, no visits during week 2 (rest week), 12 treatment visits during weeks 3-6, and one follow-up visit (no treatment) during week 10.

The non-invasive stimulation will be delivered using electrodes placed on the skin along the spine and specified limbs. Tolerability of study participants to device stimulation will be assessed by occurrence of device-related adverse events and results from several validated questionnaires to measure function, disability, and quality of life: Revised ALS Functional Rating Scaled (ALSFRS-R), Rasch Overall ALS Disability Scale (ROADS), ALS Assessment Questionnaire (ALSAQ-40).

To be eligible, individuals must meet the following inclusion criteria:

• 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 and able to give informed consent

Individuals may not be eligible to participate if they are affected by another illness or receiving another treatment that might interfere with the ability to undergo safe testing.

A full listing of inclusion and exclusion criteria is available from the study sponsor.

To learn more about the study or inquire about participation, please visit the trial website here or contact the Clinical Site Principal Investigator, Dr. Leon Morales-Quezada, at email: jmorales-quezada@mgb.org or phone: (617) 952-6162.