NCT03863704Completed
Transcutaneous VNS to Treat Pediatric IBD
Transcutaneous Vagal Nerve Stimulation to Treat Pediatric Inflammatory Bowel Disease
Source: ClinicalTrials.gov · Last updated 1 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 14 Feb 2019
- Start date
- 14 Feb 2019
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- Northwell Health
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT03863704
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 14 Feb 2019 to the primary completion date, 31 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Expectation to increase corticosteroids and/or immunosuppressive treatment
- Active treatment with antibiotics
- Presence of active intestinal infection or documented infection by stool PCR or culture analysis in the previous 6 weeks
- Continuous treatment with an anti-cholinergic medication, including over the counter medications
- Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
- 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
- Any planned surgical procedure requiring general anesthesia within the course of the study
- Participation in any other Investigational drug and/or treatment currently or planned during the length of the study
Other illness
- weighted Pediatric Crohn Disease Activity Index (wPCDAI) score \> 57.5 (severe)
- Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention
- Comorbid disease with high likelihood of requiring corticosteroid use
- Known cardiac condition causing or with potential to cause arrhythmia
Other
- Presence of bowel stricture with prestenotic dilatation
- Presence of intra-abdominal or perirectal abscess
- Pediatric UC activity Index (PUCAI) score ≥ 65 (severe)
- Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine)
- Pregnancy or Lactation
- Inability to comply with study and follow-up procedures
- Non-English speaking
Who the study is looking for
- Age 10-21 years
- IBD diagnosis for at least 3 months, confirmed by clinical, biochemical, and endoscopic evaluations
- Elevated Fecal calprotectin ≥ 200 ug/g within the past 4 weeks prior to enrollment
- Evidence of active inflammatory disease despite treatment with at least one conventional therapy
- If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 14 days before entry into study
- 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
- 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
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
Age in the registry: 10 years to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Steven & Alexandra Cohen Children's Medical Center of New York Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.