Activating the Cholinergic Anti-Inflammatory Pathway in Healthy Volunteers and People With Inflammatory Arthritis

Prior treatment

• Took a JAK inhibitor within the last 4 weeks, or likely to start one while participating in this study
• Started a Tumor Necrosis Factor (TNF) inhibitor within the last 5 months or had a change in prescription within the last 3 months
• Started a corticosteroid, had a change in prescription, or on a stable dose = or \> 10 mg of prednisone daily within the last 4 weeks
• Regular use of epinephrine like medications (cold, cough, congestion, or sinus medications, bronchodilators, appetite suppressants)
• Receiving chemotherapy or immunotherapy to treat malignancy
• Surgery or major traumatic injury in the past 90 days

Other illness

• Any physical disabilities, conditions, or diseases that limit the capacity to participate in study procedures or increase the risk of harm as determined by the study PI
• Active bacterial or viral infection
• History of substance use disorder or active regular use of substances (nicotine, marijuana, cocaine, psychedelics, stimulants, etc.)
• History of substance use disorder or likely use of substances during the study period (marijuana, opioids/heroin, cocaine, psychedelics, methamphetamine, etc.)
• Active bacterial or viral infection
• Significant immunodeficiency due to underlying illness
• Wound, rash, infection, or traumatic injury over the target area
• Clinically significant cardiovascular disease
• Uncontrolled fibromyalgia or other diffuse pain syndromes

Other

• Unable to provide informed consent
• Class II obesity with a BMI of 35 or higher
• Pregnant women or those trying to become pregnant
• Active use of tobacco/nicotine products
• Splenomegaly, asplenia, or splenectomy
  • Inflammatory Arthritis Population
• Unable to provide informed consent
• Started a conventional synthetic DMARD (csDMARD) within the last 8 weeks or had a change in prescription within the last 4 week
• Started any other biologic or targeted synthetic DMARD within the last 3 months, or likely to start one while participating in the study
• Active use of tobacco/nicotine products
• Class II obesity with a BMI of 35 or higher
• Pregnant women or those trying to become pregnant
• Vagal nerve injury or vagotomy
• Chronically-implanted medical devices (i.e. pacemaker, AICD, vagus nerve stimulator, spinal cord stimulator)
• CKD Stage 3 or higher

• 22-75 years of age
• Weigh at least 40 kg
• 22-75 years of age
• Weigh at least 40 kg
• Diagnosis of Rheumatoid Arthritis, Psoriatic Arthritis, or Axial Spondyloarthritis of at least 6 months duration as defined by ACR guidelines
• Able to continue the same stable dose of immunomodulatory medication(s) while participating in the study

Criteria the registry did not label

• Healthy Volunteer Population