Using the Cholinergic Anti-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain

Northwell Health

Status: Unknown

Conditions: Musculoskeletal Pain; Lupus Erythematosus, Systemic

Treatments: Device: Sham vagus nerve stimulation; Device: Vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02822989

16-0171

Details and patient eligibility

About

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune, inflammatory disease and musculoskeletal pain is one of the most common symptoms. This study will investigate whether transcutaneous stimulation of the vagus nerve will decrease lupus musculoskeletal pain. This study will additionally investigate the biologic effects of vagus nerve stimulation on inflammation. It will be the first clinical study using one of the body's own pathways of modulating the immune system and inflammatory response, the cholinergic anti-inflammatory pathway, in SLE.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18 years,
2. SLE (defined by the ACR or SLICC criteria),
3. Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale
4. BILAG C on Musculoskeletal Domain of the BILAG 2004
5. If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 28 days before baseline,
6. If on background immunosuppressive treatment the dose must be stable for at least 28 days before baseline
7. Able and willing to give written informed consent and comply with the requirements of the study protocol.

Exclusion criteria

1. Treatment with rituximab within one year of baseline (subjects with previous treatment with rituximab can enter study only with documentation of B cell repletion),
2. Treatment with cyclophosphamide within 2 months of baseline,
3. Expectation to increase steroids and/or immunosuppressive treatment,
4. Anti-phospholipid syndrome,
5. Fibromyalgia (fibromyalgia will be defined as a score > 13 on the Fibromyalgia Symptom Scale (FSS).
6. Treatment with an anti-cholinergic medication, including over the counter medications,
7. Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
8. Current tobacco or nicotine user,
9. Joint replacement within 60 days prior to study enrollment or planned within the course of the study,
10. Any planned surgical procedure requiring general anesthesia within the course of the study,
11. Intra-articular cortisone injections within 28 days of the start of study,
12. Chronic inflammatory disorders apart from SLE affecting the joints,
13. 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,
14. Active infection including hepatitis B or hepatitis C at baseline,
15. Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention,
16. Pregnancy or lactation,
17. Comorbid disease that may require administration of corticosteroid use,
18. Inability to comply with study and follow-up procedures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Vagus Nerve Stimulation

Active Comparator group

Description:

Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.

Treatment:

Device: Vagus nerve stimulation

Sham Vagus Nerve Stimulation

Sham Comparator group

Description:

Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.

Treatment:

Device: Sham vagus nerve stimulation