Transcutaneous Vagal Nerve Stimulation to Treat Pediatric Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Fecal Calprotectin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Subjects will be given two possible anatomic sites to apply nerve stimulation, one of which is known to induce vagal nerve stimulation and the other does not.
入排标准
- 年龄范围
- 10 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Expectation to increase corticosteroids and/or immunosuppressive treatment
- •Presence of bowel stricture with prestenotic dilatation
- •Presence of intra-abdominal or perirectal abscess
- •Pediatric UC activity Index (PUCAI) score ≥ 65 (severe)
- •weighted Pediatric Crohn Disease Activity Index (wPCDAI) score > 57.5 (severe)
- •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.
- •Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine)
- •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
- •Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention
- •Pregnancy or Lactation
- •Comorbid disease with high likelihood of requiring corticosteroid use
- •Inability to comply with study and follow-up procedures
- •Non-English speaking
- •Known cardiac condition causing or with potential to cause arrhythmia
结局指标
主要结局
Fecal Calprotectin
时间窗: 16 weeks
Change in fecal calprotectin over time
次要结局
- Pediatric Ulcerative colitis activity index (PUCAI)(16 weeks)
- Patient Reported Outcome (PRO)(16 weeks)
- Physician Global Assessment (PGA) Score(16 weeks)
- Weighted Pediatric Crohn Disease activity index (wPCDAI)(16 weeks)
- Heart Rate Variability (HRV)(16 weeks)
- Change in Whole blood stimulated cytokine levels over time(16 weeks)