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

This is an interventional treatment trial for Crohn Disease Read More

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 mild to moderate symptoms in a flare with Crohn's Disease Activity Index (CDAI) > 220 and <450 despite at least one conventional therapy (corticosteroids and/or immunosuppressives) with a stable dose will be included.
3. Elevated Fecal calprotectin ≥ 200 micro g/g within the past 4 weeks prior to enrollment
4. If on corticosteroids, the dose must be stable and ≤ 20mg/day prednisone or equivalent for at least 14 days before entry into study.
5. If on background immunosuppressive treatment the dose must be stable with the following parameters:
6. 56 days (8 weeks) for Immunomodulators (methotrexate, 6-MP, Azathioprine)
7. 112 days (16 weeks) for Infliximab, Adalimumab, Vedolizumab, Ustekinumab, another biologic
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 the Investigator.
9. Colonoscopy within the previous 1 year with no evidence of colonic dysplasia or cancer.
10. Able and willing to give written informed consent and comply with the requirements of 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 or > 450
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 the investigator 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 skin cancer.
11. Active treatment with antibiotics
12. Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks
13. Continuous treatment with an anti-cholinergic medication, including over the counter medications.
14. Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
15. Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine)
16. 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
17. Any planned surgical procedure requiring general anesthesia within the course of the study
18. Participation in any other Investigational drug and/or treatment currently or planned during the length of the study
19. Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention
20. Pregnancy or Lactation
21. Comorbid disease with high likelihood of requiring corticosteroid use
22. Inability to comply with study and follow-up procedures
23. Non-English speaking.
24. Known cardiac condition causing or with potential to cause arrhythmia
25. Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
26. Patients who have had surgery to cut the Vagus nerve in the neck (cervical vagotomy)
27. Patients with clinically significant untreated hypertension, hypotension, bradycardia, or tachycardia.
28. Have a metallic device such as a stent, bone plate or bone screw implanted at or near their neck.
29. Are using another device at the same time (e.g., TENS Unit, muscle stimulator)