Transcutaneous VNS to Treat Pediatric IBD

Exclusion Criteria

• •1. Expectation to increase corticosteroids and/or immunosuppressive treatment
• •2. Presence of bowel stricture with prestenotic dilatation
• •3. Presence of intra-abdominal or perirectal abscess
• •4. Pediatric UC activity Index (PUCAI) score ≥ 65 (severe)
• •5. weighted Pediatric Crohn Disease Activity Index (wPCDAI) score \> 57.5 (severe)
• •6. Active treatment with antibiotics
• •7. Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks
• •8. Continuous treatment with an anti-cholinergic medication, including over the counter medications
• •9. Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
• •10. Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine)
• •11. Bowel resection surgery within past 90 days prior to study enrollment and on no conventional IBD therapy, or planned surgery within the course of the study
• •12. Any planned surgical procedure requiring general anesthesia within the course of the study
• •13. Participation in any other Investigational drug and/or treatment currently or planned during the length of the study
• •14. Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention
• •15. Pregnancy or Lactation
• •16. Comorbid disease with high likelihood of requiring corticosteroid use
• •17. Inability to comply with study and follow-up procedures
• •18. Non-English speaking
• •19. Known cardiac condition causing or with potential to cause arrhythmia