Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) Study in Ulcerative Colitis

Eligibility Criteria

• 1. Age 10-39 years
• 2. UC diagnosis for at least 3 months, confirmed by standard diagnostic evaluations including clinical, biochemical, and endoscopic studies
• 3. If age 17 years or younger, a PUCAI score of 10-60
• 4. A partial Mayo score of 3-6
• 5. If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 14 days before entry into study
• 6. If on 5-Aminosalicylate, dose must be stable with following parameters:
• * 28 days on oral medication
• * 28 days on or off rectal medication
• 7. If on background immunosuppressive treatment the dose must be stable with the following parameters:
• * 56 days (8 weeks) for Immunomodulators (methotrexate, 6-MP, Azathioprine)
• * 112 days (16 weeks) for Infliximab, Adalimumab, Vedolizumab, Ustekinumab, other biologic, tofacitinib, upadacitinib, ozanimod
• 8. Able and willing to give written informed consent and comply with the requirements of the study protocol.
• 9. The earbud electrode must fit properly in the prospective subject's left ear
• 10. Fecal calprotectin of ≥150 during screening period
• 1. Expectation to increase corticosteroids and/or immunosuppressive treatment
• 2. Presence of bowel stricture
• 3. History of intra-abdominal or perirectal abscess
• 4. Disease limited to only rectum (ulcerative proctitis)
• 5. Active treatment with antibiotics
• 6. Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks
• 7. Continuous treatment with an anticholinergic medication, including over the counter medications (See appendix)
• 8. Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
• 9. Current tobacco or nicotine user including nicotine patches, gum and vaping (to limit potential confounding effects of exposure to nicotine)
• 10. Bowel resection surgery within past 90 days prior to study enrollment, or planned surgery within the course of the study
• 11. Any planned surgical procedure requiring general anesthesia within the course of the study
• 12. Participation in any other Investigational drug and/or treatment currently or planned during the length of the study
• 13. Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention
• 14. Pregnancy or Lactation
• 15. Comorbid disease with high likelihood of requiring corticosteroid use
• 16. Inability to comply with study and follow-up procedures
• 17. Individuals with prior medical history of significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and AV blocks
• 18. Individuals with existing skin lesions on the left ear