Transcutaneous VNS to Treat Pediatric IBD
| Status: | Recruiting |
|---|---|
| Conditions: | Colitis, Gastrointestinal, Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 10 - 21 |
| Updated: | 3/7/2019 |
| Start Date: | February 14, 2019 |
| End Date: | December 31, 2021 |
| Contact: | Sujay Joseph |
| Email: | sjoseph37@northwell.edu |
| Phone: | 516 472 3650 |
Transcutaneous Vagal Nerve Stimulation to Treat Pediatric Inflammatory Bowel Disease
The current available therapies for inflammatory bowel disease (IBD), including
immunomodulator and biologic medications may have toxicities limiting use or inadequate
effect. We propose a novel approach to the treatment of IBD by using transcutaneous vagal
nerve stimulation (VNS). Research has previously identified that VNS using a surgically
implanted stimulator can improve symptoms and decrease inflammation in people with
inflammatory diseases. This study will evaluate the use of non-invasive nerve stimulation
through the skin (rather than through an implanted device) as a potential therapy in
pediatric patients with Crohn Disease or ulcerative colitis. We will be evaluating how this
nerve stimulation affects symptoms, markers of inflammation found in the blood and stool
including cytokine levels, and heart rate variability. The primary hypothesis of the study is
the use of transcutaneous VNS will decrease inflammation in people with IBD leading to
improved signs and symptoms of disease. The primary endpoint of the study is to evaluate the
change in fecal calprotectin after 16 weeks of nerve stimulation. Secondary endpoints include
changes in symptom scores, blood cytokine levels, and heart rate variability.
immunomodulator and biologic medications may have toxicities limiting use or inadequate
effect. We propose a novel approach to the treatment of IBD by using transcutaneous vagal
nerve stimulation (VNS). Research has previously identified that VNS using a surgically
implanted stimulator can improve symptoms and decrease inflammation in people with
inflammatory diseases. This study will evaluate the use of non-invasive nerve stimulation
through the skin (rather than through an implanted device) as a potential therapy in
pediatric patients with Crohn Disease or ulcerative colitis. We will be evaluating how this
nerve stimulation affects symptoms, markers of inflammation found in the blood and stool
including cytokine levels, and heart rate variability. The primary hypothesis of the study is
the use of transcutaneous VNS will decrease inflammation in people with IBD leading to
improved signs and symptoms of disease. The primary endpoint of the study is to evaluate the
change in fecal calprotectin after 16 weeks of nerve stimulation. Secondary endpoints include
changes in symptom scores, blood cytokine levels, and heart rate variability.
Inclusion Criteria:
1. Age 10-21 years
2. IBD diagnosis for at least 3 months, confirmed by clinical, biochemical, and
endoscopic evaluations
3. Elevated Fecal calprotectin ≥ 200 ug/g within the past 4 weeks prior to enrollment
4. Evidence of active inflammatory disease despite treatment with at least one
conventional therapy
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
- Prior to baseline calprotectin, 28 days on rectal medication or 2 weeks 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
8. 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 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
We found this trial at
1
site
New Hyde Park, New York 11040
Principal Investigator: Benjamin Sahn, MD
Phone: 516-472-3650
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