Receive daily nerve stimulation treatment for lupus-related pain

Back to Systemic Lupus Erythematosus trials

What is this trial?

This trial is testing transcutaneous vagus nerve stimulation (taVNS)—a gentle, non-invasive treatment that stimulates the vagus nerve through the skin—to see if it can reduce muscle and joint pain and fatigue in people with systemic lupus erythematosus (SLE). A smaller earlier study showed very promising results, and this new trial will test whether longer treatment (28 days instead of 4 days) works even better and lasts longer after stopping. About half of participants will receive the real treatment, and half will receive a sham (fake) treatment to fairly measure how well this medication works.

Muscle and joint pain and fatigue affect up to 95% of lupus patients and significantly hurt their quality of life, yet safe and effective treatments for these symptoms are limited. This trial explores whether stimulating the vagus nerve could offer a new, gentle way to help control these difficult symptoms.

Do you qualify?

You likely qualify if…

you have been diagnosed with systemic lupus erythematosus (SLE) according to standard criteria
you experience muscle or joint pain rated 4 or higher on a 10-point pain scale
you have active lupus affecting your joints (meeting BILAG criteria)
your lupus medications have been stable for at least one to four weeks before starting the trial
you are able to give written consent and follow the study schedule

You likely don't qualify if…

you have started certain lupus medications (like immunosuppressants or antimalarials) within the past 3 months
you have any implanted electronic devices, such as a pacemaker, hearing aid, or deep brain stimulator
you currently use tobacco or nicotine products
you are taking anti-cholinergic medications or chronic narcotic pain medications
you are pregnant, breastfeeding, or have had recent joint surgery or planned surgery during the trial

What participation looks like

If you join this trial, you will receive either real or sham vagus nerve stimulation—a quick, painless procedure performed for just 5 minutes each day for 28 consecutive days. You'll then stop treatment and be monitored for another 28 days to see how long any benefits last. Throughout the trial, researchers will measure your pain, fatigue, and disease activity, and they may collect blood samples and other information to understand how the treatment works.

Nerve Stimulation for Lupus Pain and Fatigue

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)