SetPoint System for Multiple Sclerosis

This trial tests a device called the SetPoint System to determine if it can safely aid in repairing nerve damage in individuals with relapsing-remitting multiple sclerosis (RRMS). The device, a small implant, stimulates the vagus nerve and may promote nerve healing when used alongside standard RRMS treatments. Participants will be divided into two groups: one receiving active stimulation and the other a non-active version. The study seeks individuals who have remained stable on their RRMS medication and have not experienced a relapse or new brain lesions in the past year. As an unphased trial, it offers a unique opportunity to contribute to cutting-edge research that could lead to new treatment options for RRMS.

The trial does not specify that you need to stop your current medications. In fact, it requires participants to be on a stable regimen of disease-modifying therapy (DMT) before joining.

Research has shown that the SetPoint System is generally well-tolerated. An earlier study found the implant and its surgical placement to be safe, with only a few serious side effects related to the procedure, occurring at a low rate of 1.7% (4 out of 100 participants). This suggests that most people handled the treatment well. The system has also received approval for further study, supporting its safety. Overall, early findings suggest that the SetPoint System is a safe option for people with relapsing-remitting multiple sclerosis (RRMS).¹²³⁴⁵

The SetPoint System is unique because it uses a novel method called vagus nerve stimulation to manage multiple sclerosis (MS). Unlike standard treatments like disease-modifying therapies (DMTs) that primarily target the immune system, this system delivers electrical impulses to the vagus nerve, potentially reducing inflammation and modifying disease activity without drugs. Researchers are excited about this non-invasive approach because it opens up possibilities for fewer side effects and offers a new avenue for treating MS that could complement existing therapies.

Research has shown that the SetPoint System might repair damaged nerves in individuals with relapsing-remitting multiple sclerosis (RRMS) by promoting remyelination, the growth of new protective layers on nerve fibers. Early study results indicate that this system is safe and could reduce disease activity. In this trial, participants will join either the treatment arm, receiving active stimulation, or the control arm, receiving non-active stimulation. The SetPoint System uses a small device to stimulate the vagus nerve, potentially aiding in nerve repair. Although detailed long-term results are not yet available, initial findings are promising for improving nerve function in MS patients.²⁴⁶⁷⁸