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RecruitingPhase 2

Transcutaneous Vagus Nerve Stimulation in SLE

Transcutaneous Vagus Nerve Stimulation in SLE (TvSSLE)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 months, 28 days

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In this study, 18 patients with musculoskeletal pain will be followed for 2 months and will receive tcVNS or placebo (sham stimulation) for 5 minutes/day for 28 days."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether stimulating the vagus nerve through the skin can ease joint and muscle pain and tiredness in people with lupus (SLE). Participants use real or sham (fake) stimulation for 5 minutes a day for 28 days. The study team then follows them for 28 more days to see how long any effects last.

Systemic lupus erythematosus (SLE) is a chronic autoimmune inflammatory disease. Joint and muscle pain and fatigue are extremely common among patients and contribute to a reduced quality of life. Available therapies may be associated with significant side effects and many patients do not achieve an adequate response to these treatments. Therefore, there is an unmet need to develop new strategies to reduce pain and fatigue. Filling this need would significantly improve patients' quality of life. This trial will evaluate the effects of a novel approach, stimulating the vagus nerve, a nerve originating in the brain as a potential therapeutic intervention for treatment of musculoskeletal pain and fatigue. Vagus nerve stimulation has multiple beneficial effects and is one of the body's own ways to modulate the immune system. One can stimulate the vagus nerve via the skin at the neck or at specific locations in the ear, (transcutaneous vagus nerve stimulation: tcVNS). We recently completed a short, small scale randomized, placebo controlled trial of tcVNS in patients with SLE and observed dramatic benefits on musculoskeletal pain and fatigue. The treatment was safe without side effects. We are therefore proposing a longer trial to validate our initial findings and to look at durability. In this study, 18 patients with musculoskeletal pain will be followed for 2 months and will receive tcVNS or placebo (sham stimulation) for 5 minutes/day for 28 days. Patients will have a 1 out of 3 chance of receiving sham stimulation and neither the patient nor the evaluating investigator will know the actual treatment. The stimulations are self-administered, are non-painful and have not been associated with serious risks. After 28 days of stimulation, treatment will be discontinued and patients will be monitored for an additional 28 days to evaluate durability. Pain, fatigue and disease activity will be evaluated as well as possible side effects will be monitored throughout the trial. This study will also explore biologic mechanisms that may be responsible for the potential clinical effects. This will include possible effects of stimulation on gut permeability and the stool microbiome, areas that may play a significant role contributing to SLE disease and its manifestations. The development of an effective treatment without significant side effects would be extremely valuable and a significant advance for patients with SLE. If efficacious, tcVNS offers a non-toxic, non-immunosuppressive strategy to control two of the most common symptoms of this disease.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have lupus diagnosed using accepted medical guidelines.
  • Have joint or muscle pain rated at least 4 on a 10-point pain scale.
  • Have joint or muscle symptoms rated C or higher on the study’s lupus activity scale.
  • If taking steroids, have a steady dose equal to 10 mg or less of prednisone daily for at least 14 days before the study starts.
  • If taking drugs that lower immune system activity, have a steady dose for at least 28 days before the study starts.
  • If taking NSAIDs (pain and swelling medicines), have a steady dose for at least 7 days and agree not to change it unless it causes harm.
  • Be able and willing to sign a consent form and follow study rules.

Who can't join

  • Recently started immune-lowering drugs, antimalarial drugs, or anifrolumab (within 3 months), or belimumab (within 6 months); received cyclophosphamide within 2 months; or expect to need higher steroid or immune-lowering doses.
  • Have antiphospholipid syndrome (a blood-clotting disorder), fibromyalgia (long-lasting widespread pain), another disease causing joint swelling, or another illness that previously needed steroids.
  • Take anticholinergic medicines (drugs that block certain nerve signals), including store-bought drugs; use narcotic pain drugs long term; or currently use tobacco or nicotine.
  • Have an implanted electronic device, such as a pacemaker, defibrillator, hearing aid, cochlear implant, or brain stimulator; or previously received vagus nerve stimulation through the ear in a trial.
  • Had joint replacement within 60 days, plan joint replacement or surgery requiring general anesthesia during the study, or had a cortisone shot into a joint within 28 days of the start.
  • Used an experimental treatment too recently: within 28 days before study treatment, or within the time needed for the drug’s amount in the body to halve seven times, whichever is longer.
  • Have an active infection, including hepatitis B or C; are pregnant or breastfeeding; or have a known allergy to mannitol or lactulose.
  • Have any condition the study doctor thinks makes treatment unsafe, or cannot follow study and follow-up steps.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * SLE (defined by the ACR or SLICC criteria), * Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale, * BILAG C or greater on the Musculoskeletal Domain of the BILAG 2004, * If on corticosteroids, the dose must be stable and ≤ 10 mg/day (prednisone or equivalent) for at least 14 days before baseline, * If on background immunosuppressive treatment the dose must be stable for at least 28 days before baseline, * If on NSAIDS, the dose must be stable for at least 7 days before baseline and the subject must be willing not to change the dose during the trial (except for toxicity), * Able and willing to give written informed consent and comply with the requirements of the study protocol. Exclusion Criteria: * Initiation of immunosuppressive or antimalarial treatment within 3 months of baseline, * Treatment with cyclophosphamide within 2 months of baseline, * Initiation of anifrolumab within 3 months of baseline * Initiation of belimumab within 6 months of baseline, * Expectation to increase steroids and/or immunosuppressive treatment, * Anti-phospholipid syndrome, * Fibromyalgia, * Treatment with an anti-cholinergic medication, including over the counter medications, * Any implantable electronic devices including pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators, * Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine), * Joint replacement within 60 days prior to study enrollment or planned within the course of the study, * Any planned surgical procedure requiring general anesthesia within the course of the study, * Intra-articular cortisone injections within 28 days of the start of study, * Chronic inflammatory disorders apart from SLE affecting the joints, * Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (Day 0), whichever is the greater length of time, * Active infection including hepatitis B or hepatitis C at baseline, * Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention, * Pregnancy or lactation (Pregnancy status will be determined via serum blood test \& lactation will be determined via self-report), * Comorbid disease that has previously required administration of corticosteroid use, * Known allergy to mannitol or lactulose, * Chronic treatment with narcotic medication, * Prior receipt of transauricular vagus nerve stimulation in a clinical trial, * Inability to comply with study and follow-up procedures.

Study sites (1)

NY