Transcutaneous vagus nerve stimulation for muscular pain and fatigue in SLE

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 randomized, sham-controlled trial will compare active transcutaneous vagus nerve stimulation (tcVNS) to sham stimulation in adults with SLE and musculoskeletal pain. Participants will receive 28 days of stimulation, followed by 28 days of observation to assess durability of any benefits. The study will measure pain, fatigue, overall disease activity, and safety, and will explore potential biological mechanisms such as gut permeability and microbiome changes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Feinstein Institutes for Medical Research
  Manhasset, New York, United States Recruiting

Study contacts

• Principal investigator: Cynthia Aranow, MD — Northwell Health
• Study coordinator: Sanita Kandasami
• Email: skandasami@northwell.edu
• Phone: 516 562-2401

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.