Vagus Nerve Stimulation for Rheumatoid Arthritis

Not currently recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SetPoint Medical Corporation

Disqualifiers: Inability to consent, adverse event, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for rheumatoid arthritis using a device that stimulates the vagus nerve, which may help control inflammation. The goal is to determine if the SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System is safe and effective for individuals who haven't responded to at least two different standard medications. Participants should have moderate-to-severe rheumatoid arthritis and have previously participated in a related study called SPM-008. The trial compares two different frequencies of nerve stimulation to identify the most effective one. As an unphased trial, it offers patients a unique opportunity to explore innovative treatments that could potentially improve their condition.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this Vagus Nerve Stimulation device is safe for rheumatoid arthritis?

Research has shown that vagus nerve stimulation (VNS) is generally safe for treating rheumatoid arthritis. In a study with 15 patients, the device was well-tolerated and reduced symptoms in those unresponsive to other treatments. With use in over 100,000 patients, the device demonstrates a strong safety record. While minor side effects can occur, serious problems are rare. The FDA has also approved this treatment for reducing inflammation, further supporting its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of vagus nerve stimulation for rheumatoid arthritis because it offers a unique, non-drug approach to managing inflammation. Unlike standard treatments, which often rely on medications like NSAIDs, corticosteroids, or biologics, this method targets the body’s cholinergic anti-inflammatory pathway directly through neurostimulation. This approach could reduce inflammation with fewer side effects and potentially provide a new option for patients who don't respond well to existing therapies. The treatment involves two different stimulation frequencies, QD (once daily) and QID (four times daily), allowing for personalized treatment options.

What evidence suggests that this Vagus Nerve Stimulation device is effective for rheumatoid arthritis?

Research has shown that Vagus Nerve Stimulation (VNS) can reduce symptoms in people with rheumatoid arthritis, particularly those unresponsive to other treatments. In one study, 50% of patients experienced improvement in their arthritis symptoms after using a VNS device. This improvement occurred when other treatments had failed. Previous patients found this treatment safe and easy to manage. The device affects the body's nervous and immune systems, helping to control inflammation, a key factor in rheumatoid arthritis. This trial will compare two dosing schedules of VNS: one group will receive active stimulation once daily (QD), while another group will receive active stimulation four times daily (QID). These findings suggest VNS may offer a promising new option for those struggling with this condition. ^{1 2 3 6 7}

Who Is on the Research Team?

Alan Kivitz, MD

Principal Investigator

Altoona Center for Clinical Research

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe rheumatoid arthritis who didn't fully respond to at least two advanced treatments. Participants must have completed a prior 12-week treatment in Study SPM-008 and, if they can bear children, agree to use reliable contraception during the study.

Inclusion Criteria

Women of childbearing potential must not be pregnant and must agree to use a reliable method of contraception throughout the study

I completed 12 weeks in Study SPM-008.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active vagus nerve stimulation with output current adjustments during the initial weeks

5 weeks

Visits at Day 0, Week 1, 2, 3, 4, and 5

Long-term Treatment

Participants continue receiving maximally tolerated output current as 1 min QD or 1 min QID treatment

31 months

Follow-up visits at Week 8, Week 12, Months 6, 9, 12, 18, 24, 30, 33, and 36

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System

Trial Overview The trial is testing the long-term safety and effectiveness of a Vagus Nerve Stimulation (VNS) device by SetPoint Medical. It's designed for patients whose arthritis hasn't improved enough with previous drug therapies.

How Is the Trial Designed?

Group I: Active stimulation QD Active Control 1 Intervention

Group II: Active stimulation QID Active Control 1 Intervention

Who Is Running the Clinical Trial?

SetPoint Medical Corporation

Lead Sponsor

Trials

8

Recruited

400+

Citations

1. setpointmedical.com setpointmedical.com/setpoint-medical-announces-late-breaking-data-from-reset-ra-study-at-acr-convergence-2024/

SetPoint Medical Announces Late-Breaking Data from ... New positive data demonstrate promising clinical benefits of Company's neuroimmune modulation platform through 24-week follow-up.

2. setpointmedical.com setpointmedical.com/

SetPoint Medical – Start Activating Vagus Nerve Stimulation Proves Effective in Refractory Rheumatoid Arthritis. November 21, 2024. SetPoint Medical Receives FDA's IDE Approval for U.S. Pilot ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03437473

Safety and Efficacy of Vagus Nerve Stimulator in Patients ... Multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in 15 adult patients with ...

4. setpointmedical.com setpointmedical.com/the-lancet-rheumatology-publishes-clinical-trial-data-demonstrating-promising-safety-and-efficacy-profile-for-a-novel-bioelectronic-device-in-patients-with-drug-refractory-rheumatoid-arthritis/

The Lancet Rheumatology Publishes Clinical Trial Data ... Device reduced disease activity in 50% of patients who had failed multiple drug classes including Janus Kinase Inhibitors (JAKi).

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38273617/

Safety and efficacy of neurostimulation with a miniaturised ... VNS with a miniaturised neurostimulator was safe and well tolerated and reduced signs and symptoms of rheumatoid arthritis in patients with multidrug- ...

6. setpointmedical.com setpointmedical.com/clinical-evidence/

Clinical Evidence While the SetPoint System is the first device proven safe for treatment of RA, devices to stimulate the vagus nerve have been implanted in 100,000 patients for ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04862117

Long Term Extension of Safety and Efficacy of Vagus ... A multicenter, extension study to assess long term safety and efficacy of an active implantable VNS device in adult patients with rheumatoid arthritis.