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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
To apply transcutaneous electrical stimulation using a TENS unit to the ear or the leg.
Steven & Alexandra Cohen Children's Medical Center of New York
New Hyde Park, New York, United States
Fecal Calprotectin
Change in fecal calprotectin over time
Time frame: 16 weeks
Change in Whole blood stimulated cytokine levels over time
Blood will be collected into 2 tubes, one with no stimulant and the other with lipopolysaccharide (LPS) to stimulate macrophages to produce cytokines. Cytokine levels within the blood will be assessed and compared to baseline levels. The cytokines being assayed include tumor necrosis factor-alpha, Interferon-gamma, Transforming Growth Factor-beta and Interleukins (IL) - 1, 6, 10, 12, 17, 18, 23. Samples will be collected for this analysis at week 0, 2, 4, and 24
Time frame: 16 weeks
Patient Reported Outcome (PRO)
PROMIS Pediatric Profile v2.0-25 and PROMIS Parent Proxy v2.0- 25 questionnaires to evaluate the effect of VNS on abdominal pain intensity and interference in daily activities, fatigue, anxiety, depression, physical function and peer relationships
Time frame: 16 weeks
Pediatric Ulcerative colitis activity index (PUCAI)
Change in Pediatric ulcerative colitis activity index over time
Time frame: 16 weeks
Weighted Pediatric Crohn Disease activity index (wPCDAI)
Change in weighted Pediatric Crohn Disease activity index over time
Time frame: 16 weeks
Physician Global Assessment (PGA) Score
Change in physician global assessment score over time
Time frame: 16 weeks
Heart Rate Variability (HRV)
Evaluating change in HRV from baseline until study completion
Time frame: 16 weeks
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