Pilot trial tests nerve stimulator to repair myelin damage in RRMS

A pilot clinical trial in the U.S. is enrolling people with relapsing-remitting multiple sclerosis (RRMS) to test Setpoint Medical’s implantable nerve stimulation device, which is designed to reduce inflammation and promote myelin repair.

The trial (NCT06796504) is enrolling up to 60 people, ages 22-50, and will evaluate the safety and potential remyelinating effects of the device when used alongside standard disease-modifying therapies (DMTs).

“Our approach to activating the body’s innate neuroimmune pathways offers a compelling and novel mechanism that could complement current standards of care of multiple sclerosis,” David Chernoff, MD, chief medical officer of Setpoint, said in a company press release.

The first participants have been enrolled at the Shepherd Center’s Andrew C. Carlos MS Institute in Georgia and the UW Medicine Multiple Sclerosis Center in Seattle. Patients are also being recruited at the Minnesota Center for Multiple Sclerosis, West Virginia University, Johns Hopkins University in Maryland, UT Medicine Multiple Sclerosis and Neuroimmunology Center in Texas, and the University of Texas Health Science Center at Houston.

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Restoring myelin ‘essential’ to preserving function

MS is an autoimmune disease characterized by inflammation of the myelin sheath in the brain and spinal cord. Myelin is a protective coating around nerve fibers that is essential for the rapid transmission of nerve signals. Damage to this sheath disrupts nerve communication, leading to MS symptoms.

Most approved DMTs for MS are designed to reduce inflammation and lower the risk of relapses or new disease activity on MRI scans. Many of these therapies can slow the accumulation of disability over time, but they do not directly repair damage to myelin, which could potentially reverse symptoms and restore lost functions. Restoring myelin is considered a major unmet need in MS, and therapies are now being developed to boost myelin repair.

“Remyelination is one of the most critical yet unmet clinical needs in the treatment of multiple sclerosis,” said Jacqueline Rosenthal, MD, medical director of the MS Institute and principal investigator of the study at Shepherd Center. “While current therapies focus largely on suppressing inflammation, restoring the damaged myelin sheath is essential for preserving neuronal function and preventing long-term disability.”

SetPoint’s approach aims to restore myelin by electrically stimulating the vagus nerve, one of the longest nerves in the body that runs from the head to the abdomen. The vagus nerve helps regulate many body functions, and is involved in the inflammatory reflex pathway, which can help dial down excessive inflammation and restore immune balance.

The device is about the size of an oral capsule and is implanted in the left vagus nerve region of the neck through a small incision. It runs on a rechargeable battery that can be recharged wirelessly, and its electrical pulses can be precisely adjusted by providers via an iPad application.

“Neuroimmune modulation is hypothesized to recalibrate immune activity while supporting the conditions necessary for myelin repair, and offers an innovative avenue to evaluate whether meaningful remyelination can be achieved in patients living with MS,” Rosenthal said.

In a rat model of MS-like demyelination, vagus nerve stimulation reduced the activation of inflammatory cells, including microglia and astrocytes, and was associated with improved myelin repair in lesions, supporting its potential as a remyelination strategy.

Preclinical studies showed vagus nerve stimulation reduced immune cell activity in areas of myelin damage and promoted myelin repair, supporting its potential as a remyelination strategy.

Participants in the pilot trial will receive the implanted device, but only about two-thirds will have it activated at the start. They will receive stimulation for one minute each day for 48 weeks (nearly one year). The remaining participants will receive nonactive stimulation and serve as controls. After 48 weeks, those in the control group may switch to active stimulation, and all participants will be followed for another 48 weeks to determine long-term safety.

The study is being conducted under an investigational device exemption from the U.S. Food and Drug Administration (FDA), a designation that allows an experimental medical device to be tested in a clinical trial to collect safety and effectiveness data.

The FDA has also granted the device breakthrough designation for RRMS. This status is intended to speed the development and review of technologies for life-threatening or chronically debilitating diseases that may offer significant advantages over existing treatments. The device has also been accepted into the agency’s Total Product Life Cycle Advisory Program, which provides earlier and more frequent interaction with regulators to help accelerate patient access.

A version of the system is approved in the U.S. for certain adults with rheumatoid arthritis.