$2M grant supports new clinical trial of MyoRegulator for ALS

Pathmaker device aims to ease hyperexcitability that damages motor neurons

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The U.S. Department of Defense (DoD) has awarded more than $2 million to help Pathmaker Neurosystems conduct a second clinical trial of its MyoRegulator — an experimental, noninvasive nerve modulating device — in people with amyotrophic lateral sclerosis (ALS).

“We are very pleased to have DoD’s support as we launch our second clinical trial for our non-invasive ALS neuromodulation platform,” Nader Yaghoubi, MD, PhD, co-founder and CEO of Pathmaker and principal investigator on the program, said in a company press release.

The trial is expected to begin enrolling patients “in the coming months,” Yaghoubi said, and it was designed and will be conducted by a team of experts.

In addition to Yaghoubi, they include Zaghloul Ahmed, PhD, a physical therapist and PathMaker’s scientific founder; Leon Morales-Quezada, MD, PhD, a professor of physical medicine and rehabilitation at Spaulding Rehabilitation Hospital; Sabrina Paganoni, MD, PhD, a professor of neurology at Harvard Medical School and co-director of the Neurological Research Institute at Massachusetts General Hospital; and Courtney McIlduff, MD, director of the ALS clinic at Beth Israel Deaconess Medical Center.

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Hyperexcitability is thought to damage motor neurons in ALS patients

ALS is caused by damage to and the gradual death of nerve cells responsible for movement, known as motor neurons, and it is marked by disease symptoms such as muscle weakness and issues with moving, speaking, and swallowing.

The biological mechanisms that drive motor neuron damage in ALS aren’t fully understood, but one process that’s thought to play a role is hyperexcitability. Hyperexcitability basically means that a nerve cell is firing electrical signals more often than it should, which can wear out and damage the cell.

MyoRegulator is a device designed to modulate nerve signaling with the aim of easing hyperexcitability, ultimately lessening nerve damage. It works by applying disposable electrodes to certain skin regions on top of the spinal cord, which deliver a gentle electrical current that reduces hyperexcitability in spinal motor neurons.

Pathmaker is developing the device as a potential nonpharmacological option to slow ALS progression.

The new expanded pilot study, dubbed CALM (short for “Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability”), will take place at two centers in Boston: Spaulding Rehabilitation Hospital and Beth Israel Deaconess Medical Center. Pathmaker did not provide details about the study’s expected design.

The trial is being supported by a $2.16 million grant as part of the DoD’s ALS research program. This is the second study assessing the MyoRegulator in ALS patients. A first trial, launched last year at Spaulding, has been completed, Pathmaker reported in its release. Study results have not yet been announced.

Pathmaker also completed two studies of the device in people who have experienced stroke, with early data indicating the device may help to improve their motor function.