Non-invasive Vagus Nerve Stimulation in the Treatment of Crohn's Disease - A Pilot Study

Inclusion Criteria:

1. Crohn's disease diagnosis for at least 3 months, confirmed by clinical, biochemical,and endoscopic evaluations.

2. Patients with CD involving the small bowel and / or colon with active symptoms withCrohn's Disease Activity Index (CDAI) > 220 despite at least one conventionaltherapy (corticosteroids and/or immunosuppressives) with a stable dose will beincluded.

3. Elevated Fecal calprotectin ≥ 200 micro g/g within the past 4 weeks prior toenrollment

4. If on corticosteroids, the dose must be stable and ≤ 20mg/day prednisone orequivalent for at least 14 days before entry into study.

5. If on background immunosuppressive treatment the dose must be stable with thefollowing parameters:

6. 56 days (8 weeks) for Immunomodulators (methotrexate, 6-MP, Azathioprine) and smallmolecules (upadacitinib)

7. 112 84 days (16 12 weeks) for biologics (Infliximab, Adalimumab, Vedolizumab,Ustekinumab, another biologic Risankizumab)

8. Clinical laboratory evaluations (including a chemistry panel, complete blood count [CBC], and urinalysis [UA]) within the reference range for the test laboratory,unless a typical consequence of CD or deemed not clinically significant by theInvestigator.

9. Colonoscopy within the previous 1 year with no evidence of colonic dysplasia orcancer.

10. Able and willing to give written informed consent and comply with the requirementsof the study protocol.

Exclusion Criteria:

1. Expectation to increase corticosteroids and/or immunosuppressive treatment

2. Presence of bowel stricture with pre-stenotic dilatation

3. Presence of intra-abdominal or perirectal abscess

4. Crohn's Disease Activity Index (CDAI) < 220

5. Fistula with clinical or radiological evidence of abscess

6. Perianal CD with or without rectal involvement

7. Ileostomy, colostomy, enteral or parenteral feeding

8. Short gut syndrome.

9. Clinical condition medically or surgically unstable that, at the discretion of theinvestigator would not be compatible with the patient's participation in the study

10. Any malignant neoplasia, in the year prior to screening ,except for nonmelanoma skincancer.

11. Active treatment with antibiotics

12. Presence of active intestinal infection or documented infection by stool PCR orculture analysis in the previous 6 weeks

13. Continuous treatment with an anti-cholinergic medication, including over the countermedications.

14. Implantable electronic devices such as pacemakers, defibrillators, hearing aids,cochlear implants or deep brain stimulators.

15. Current tobacco or nicotine user within the past 4 weeks (to limit potentialconfounding effects of exposure to nicotine)

16. Bowel resection surgery within past 90 days prior to study enrollment and on noconventional IBD therapy, or planned surgery within the course of the study

17. Participation in any other Investigational drug and/or treatment currently orplanned during the length of the study 19. Any condition which, in the opinion ofthe investigator, would jeopardize the subject's safety following exposure to astudy intervention 20. Pregnancy or Lactation 21. Comorbid disease with highlikelihood of requiring corticosteroid use 22. Inability to comply with study andfollow-up procedures 23. Non-English speaking. 24. Known cardiac condition causingor with potential to cause arrhythmia 25. Patients diagnosed with narrowing of thearteries (carotid atherosclerosis) 26. Patients who have had surgery to cut theVagus nerve in the neck (cervical vagotomy) 27. Patients with clinically significantuntreated hypertension, hypotension, bradycardia, or tachycardia.

18. Have a metallic device such as a stent, bone plate or bone screw implanted at ornear their neck.

19. Are using another device at the same time (e.g., TENS Unit, muscle stimulator)