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<a href="https://pmneuro.com/" rel="nofollow">PathMaker Neurosystems</a> has launched a Phase 1 clinical trial that will test its experimental noninvasive nerve-modulating device in people with <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS).
This is the first time that the device — called the <a href="https://pmneuro.com/r-d/alsuppressor/">MyoRegulator</a> and designed to slow disease progression in ALS — will be formally tested in humans. The newly launched trial is being carried out in conjunction with Spaulding Rehabilitation Hospital in Charlestown, Massachusetts.
&#8220;We are tremendously excited to launch this first-in-human trial of MyoRegulator in ALS,&#8221; Nader Yaghoubi, MD, PhD, co-founder and CEO of PathMaker, said in a <a href="https://www.globenewswire.com/news-release/2023/09/14/2743055/0/en/PathMaker-Neurosystems-Announces-Initiation-of-First-in-Human-Trial-in-ALS-for-Non-Invasive-Neuromodulation-Device.html">company press release</a>.
&#8220;Initiating clinical evaluation of our technology in ALS is not only a significant milestone for our company, but a step towards meeting the medical needs of people living with this disease,&#8221; Yaghoubi added.
In a <a href="https://rally.massgeneralbrigham.org/study/als_myoregulator">webpage</a> about the trial, researchers note that &#8220;there are currently a limited number of treatments available for ALS, most of which are pharmaceutical in nature. This study could open a path for a non-invasive, non-pharmaceutical option.&#8221;
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<h3>Device from PathMaker seeks to slow disease progression</h3>
<a href="https://alsnewstoday.com/causes-of-als/">ALS is caused</a> by the progressive dysfunction and death of motor neurons, which are the specialized nerve cells that control movement. The loss of motor neurons disrupts the brain&#8217;s ability to send signals to the body to trigger voluntary movements, ultimately leading to <a href="https://alsnewstoday.com/als-symptoms/">symptoms</a> like weakness and paralysis.
Although it&#8217;s not known exactly what drives motor neuron dysfunction in ALS, one process that&#8217;s thought to play a role is motor neuron hyperexcitability — the tendency for nerve cells to fire, or send electrical signals, more frequently than they should. Hyperexcitability and abnormal nerve firing can put strain on motor neurons, driving damage in the long run.
The PathMaker MyoRegulator device aims to reduce hyperexcitability in ALS motor neurons, with the ultimate goal of helping to preserve motor neuron health to slow disease progression.
The device uses disposable electrodes that are applied to the skin to deliver a gentle electrical current to specific parts of the spinal cord, with the aim of reducing hyperexcitability in spinal motor neurons.
&#8220;Our non-invasive approach seeks to suppress spinal motor neuron hyperexcitability, which is a key characteristic of the ALS disease process that has been found in both sporadic and familial variants of ALS,&#8221; Yaghoubi said.
The Phase 1 trial is a single-arm and open-label study, meaning that all participants will get the same treatment and all will know what treatment they&#8217;re getting, with no placebo or inactive treatment option. It will enroll adult ALS patients at Spaulding who will be required to make 16 visits to the hospital over a 10-week period.
[quote=&#8221;center&#8221;]Our non-invasive approach seeks to suppress spinal motor neuron hyperexcitability, which is a key characteristic of the ALS disease process that has been found in both sporadic and familial variants of ALS.[/quote] 
The study&#8217;s main goal is to assess the safety and feasibility of using the MyoRegulator device in people with ALS. Researchers also aim to collect preliminary data on the efficacy of the device in ALS.
PathMaker is collaborating in the trial with leading experts in the field, including Leon Morales-Quezada, MD, PhD, director of the Integrative Rehabilitation Lab at Spaulding, and Sabrina Paganoni, MD, PhD, professor of physical medicine and rehabilitation at Spaulding and a physician-scientist at Massachusetts General Hospital.
The trial is being financially supported by the <a href="https://alsnewstoday.com/news/mda-600k-support-myoregulator-alternative-als-treatment/">Muscular Dystrophy Association</a> (MDA), with grants also awarded by the <a href="https://alsnewstoday.com/news/private-philanthropy-london-cerf-prizes-als-research-projects/">Cullen Education and Research Fund</a> (CERF) and the <a href="https://alsnewstoday.com/news/nih-awards-pathmaker-371k-advance-als-neuromodulation-therapy/">National Institutes of Health</a> (NIH).

PathMaker launches first human trial to test noninvasive ALS device

The <a href="https://www.mda.org/">Muscular Dystrophy Association</a> (MDA) has invested $600,000 in <a href="https://pmneuro.com/" rel="nofollow">PathMaker Neurosystems</a> to help bring a potential noninvasive neuromodulator for <a href="https://alsnewstoday.com/what-is-als/">amyotrophic lateral sclerosis</a> (ALS) into an initial clinical trial.
Funding through the <a href="https://www.mda.org/science/mda-venture-philanthropy">MDA Venture Philanthropy</a> (MVP) program will support an early feasibility study in a small group of people to determine the safety and feasibility of PathMaker&#8217;s MyoRegulator ALS device in suppressing motor neuron hyperexcitability in ALS.
“We are truly grateful and honored to have received the support of MDA through the MVP program as we prepare for the clinical application of our non-invasive approach in ALS,” Nader Yaghoubi, MD, PhD, co-founder and CEO of PathMaker, said in a <a href="https://www.globenewswire.com/news-release/2023/01/17/2589706/0/en/Muscular-Dystrophy-Association-Awards-Venture-Philanthropy-Funding-to-PathMaker-Neurosystems-to-Develop-Neuromodulation-Treatment-for-ALS.html">company press release</a>.
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<h3>MyoRegulator device as a noninvasive, alternative ALS treatment</h3>
ALS is marked by the progressive death of motor neurons, the nerve cells that control movement. The exact <a href="https://alsnewstoday.com/causes-of-als/">causes of the disease</a> are not fully understood, but motor neuron hyperexcitability, in which these neurons are more likely to send electrical signals in response to stimuli, is a common feature contributing to neuronal damage in ALS.
Consequently, suppressing this overactivity is seen as a possible alternative treatment option.
PathMaker&#8217;s <a href="https://pmneuro.com/r-d/alsuppressor/">MyoRegulator ALS</a> device uses neuromodulation to ease motor neuron hyperexcitability, which is expected to decrease neuronal damage and slow ALS progression.
Using disposable electrodes applied to the skin, the technology delivers an electric current to areas of the spinal cord that help to restore the normal neuronal activity in spinal motor neurons.
&#8220;We have developed a robust package of pre-clinical data that &#8230; includes electrophysiology [electrical activity], biochemistry, motor function and survival studies in the gold standard ALS models,&#8221; the company said on <a href="https://pmneuro.com/r-d/alsuppressor/">its website</a>.
&#8220;PathMaker&#8217;s noninvasive approach to the treatment of ALS stands out for its innovation and already shows great potential in pre-clinical studies,&#8221; said Sharon Hesterlee, PhD, the MDA&#8217;s chief research officer. &#8220;We are excited to be part of the development of this unique technology and look forward to its application in clinical trials.&#8221;
The U.K.-based Cullen Education and Research Fund (CERF) awarded PathMaker its $250,000 Medical Electronics Prize in 2022 to further develop its external device to lower nerve activation in ALS. In 2021, the National Institutes of Health also <a href="https://alsnewstoday.com/news/nih-awards-pathmaker-371k-advance-als-neuromodulation-therapy/">awarded PathMaker $371,000</a> to advance it as an ALS treatment.
&#8220;Our technology works by suppressing overactive spinal motor neurons found in people with ALS and could represent a new therapeutic treatment modality for this devastating disease. We are very pleased to have the support of MDA and its network of clinicians and patient advocacy groups,&#8221; Yaghoubi said.
PathMaker Neurosystems reports that its is working on noninvasive systems designed to treat the approximately 48 million people in the U.S., Europe, and Asia with ALS, <a href="https://www.globenewswire.com/en/news-release/2022/03/07/2397701/0/en/PathMaker-Neurosystems-Initiates-U-S-Multi-Center-Trial-Evaluating-MyoRegulator-for-the-Non-Invasive-Treatment-of-Post-Stroke-Spasticity.html" rel="nofollow">stroke</a>, spinal cord injury, cerebral palsy, <a href="https://multiplesclerosisnewstoday.com/2019/02/12/direct-nerve-stimulation-using-myoregulator-system-seen-to-reduce-spasticity-in-mice-with-spinal-injury/">multiple sclerosis</a>, and other severe neurological conditions. Work here includes use of the device in easing the muscle stiffness, twitches and contractions — collectively called <a href="https://alsnewstoday.com/symptoms-of-als-2/">spasticity</a> — that can interfere with movement and speech and cause pain or discomfort.

Tag: MyoRegulator ALS

PathMaker launches first human trial to test noninvasive ALS device

MDA Awards $600K to Support Neuromodulator in Slowing ALS