💬In plain words
What the trial is, and whether it could suit you
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 spe
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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