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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02822989
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Northwell Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Cynthia Aranow, M.D.
Principal Investigator Affiliation	Northwell Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lupus Erythematosus, Systemic, Musculoskeletal Pain

Arms & Interventions

Arms

Active Comparator: Vagus Nerve Stimulation

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

Sham Comparator: Sham Vagus Nerve Stimulation

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

Interventions

Device: - Vagus nerve stimulation

Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.

Device: - Sham vagus nerve stimulation

Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Feinstein Institute, Manhasset, New York

Status

Address

Feinstein Institute

Manhasset, New York, 11030

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