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Can a nerve stimulator calm rheumatoid arthritis?

NCT ID NCT04862117

Disease control Sponsor: SetPoint Medical Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study tests whether an implantable vagus nerve stimulation device can safely reduce symptoms of rheumatoid arthritis in adults who have not gotten enough relief from at least two biologic or targeted synthetic DMARDs. Participants receive the device, which sends electrical pulses to the vagus nerve to potentially dampen inflammation. Researchers track side effects and measure changes in disease activity using standard arthritis scores.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
An implantable vagus nerve stimulation device that sends electrical pulses to the vagus nerve to calm inflammation
What this could lead to
If it works, this could offer a drug-free option for people with rheumatoid arthritis who have not responded to multiple medications.
What could go wrong
This is a small, early-stage extension study, so results may not apply broadly. The device requires surgery, and risks include infection, device-related side effects, or no added benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

14 people

The number who actually took part.

Started

Jul 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Subjects must have enrolled and completed 12 weeks of treatment in Study SPM-008 2. Women of childbearing potential must not be pregnant and must agree to use a reliable method of contraception throughout the study Exclusion Criteria: 1. Inability to provide consent 2. An adverse event during Study SPM-008 which precludes participation in this study 3. Any condition per the investigator's clinical judgement that precludes participation in the study

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

Contacts and locations

Locations

  • Altoona Center for Clinical Research

    Duncansville, Pennsylvania, 16635, United States

  • Arthritis & Rheumatic Disease Specialties

    Aventura, Florida, 33180, United States

  • Florida Medical Clinic, PA

    Zephyrhills, Florida, 33542, United States

  • Northwell Health

    Great Neck, New York, 11021, United States

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