Status:
NOT_YET_RECRUITING
Transcutaneous Vagus Nerve Stimulation in SLE
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
Lupus Research Alliance
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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. Avai...
Detailed Description
Musculoskeletal (MS) pain and fatigue are common symptoms of patients with Systemic Lupus Erythematosus (SLE) affecting up to 95% and contributing to a reduced quality of life. Safe and efficacious tr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06987565
Start Date
May 15 2025
End Date
May 1 2027
Last Update
May 23 2025
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