Therapeutic Potential and Neuroimmune Mechanisms of Vagal Nerve Stimulation on Gastrointestinal Motility and Inflammation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time
研究概览
简要总结
This study is investigating a new form of treatment for a digestive disorder called gastroparesis. Gastroparesis is thought to be caused by a mix of inflammation and neural dysfunction. The vagal nerve is a large nerve originating from the brain that regulates digestive function. Patients with gastroparesis have what is a called a low vagal tone which results in gastrointestinal motility problems and inflammation; therefore, investigators hypothesize that increasing vagal tone through a hand-held vagal nerve simulator will reduce inflammation and gastrointestinal motility problems in gastroparesis patients. Investigators will evaluate this hypothesis through the use of upper endoscopy testing, breath testing, and blood, stool, urine, heart rate variability, and saliva testing before and after 4 weeks of vagal nerve stimulation (VNS) treatment.
There are 6 research visits
Visit 1 and visit 2 may take up to 8 weeks (screening/baseline) Visit 3 and visit 4 will take 4 weeks (VNS treatment) visit 5 and 6 will take approximately 4 weeks (VNS followup/washout)
Consequently, it is possible that if a patient were to be at the farthest ends of visit windows, they could potentially be in the study for approx 16 weeks. Visit 1 and 2 may be less than 8 weeks which would shorten the patient's overall involvement in the study.
The treatment phase of the study will always be 4 weeks with an additional 4 week washout phase.
Use of the VNS device takes 4 weeks. Endoscopy and blood work are taken before and after the treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female.
- •Age 21-65 years old.
- •Established diagnosis of functional dyspepsia, idiopathic or diabetic gastroparesis as per AGA (American Gastroenterology Association) guidelines.
- •Patient is capable of giving informed consent and undergo upper endoscopy.
- •Patient is on stable doses of other medications for gastroparesis for preceding 4 weeks prior to enrollment (baseline measures).
- •Exclusion Criteria
- •Surgical-related gastroparesis
- •Extrinsic myopathy or neuropathy causing gastroparesis.
- •Use of narcotic pain medications in the preceding 2 weeks of study enrollment.
- •Patients with enteric feeding tubes or requiring parenteral nutrition (Patients with g-tubes who are stable for 3 months and not using the g-tube for venting may be eligible. patient with J-tubes are not eligible.
- •Patients with severe flare requiring hospitalization.
- •Untreated significant depression or suicidal thoughts.
- •Pregnant or breast-feeding women.
- •History of gastric pacemaker implantation.
- •Patients with prior gastric surgery, including fundoplication, partial/total gastrectomy, or gastric bypass.
- •Patients with malabsorption of enteric, pancreatic, or hepatibiliary etiology.
- •Patients with primary pulmonary disorders that affect the spirulina breath test.
- •Patients with implantable electronic devices.
- •Patients with carotid artery atherosclerosis.
排除标准
- 未提供
结局指标
主要结局
Effect of Vagal Nerve Stimulation on the Gastric Emptying Spirulina Breath Test Emptying Time
时间窗: Baseline and week 4 (3 hours to assess at each time point)
Investigators will measure a change in gastric emptying time before and after vagal nerve stimulation as measured in minutes. Higher number (longer times) indicate more severe gastroparesis.
Effect of Vagal Nerve Stimulation on Gastroparesis Symptoms as Measures by the Gastroparesis Cardinal Symptom Index Daily Diary (GCSI-DD) Questionnaire.
时间窗: Baseline (2 weeks prior to initiation), week 4 (7 days), week 8 (7 days)
Investigators will send daily GCSI-DD to patients for 8 weeks. This 10 item questionnaire measures the severity of gastroparesis symptoms on a scale 0-5. 0=none, 1=very mild, 2=mild, 3=moderate, 4=severe, 5=very severe. Investigators hypothesize a change of more than 0.75 points. Scored were recorded daily at each time point and scores then averaged to produce an overall score (range: 0 to 5, higher scores correspond to worse symptoms).
次要结局
- Heart Rate Variability (HRV) as a Measure of the Effect of VNS Therapy on Vagal Tone(Baseline, week 4, week 8)
- PROMIS Pain Interference Questionnaire Score as a Measure of the Effect of VNS Therapy on Overall Pain(Baseline, week 4, week 8)
- Short Form 12 (SF-12) Score the Effect of VNS Therapy on Overall Wellbeing and Health(Baseline, week 4, week 8)
- Number of Participants With Any Serious or Treatment-emergent Adverse Event (AE) as a Measure of the Safety and Tolerability of VNS in Patients With Gastroparesis(8 weeks)
- Effect of VNS on Mucosal Inflammation(Baseline (pre-VNS) and 4 weeks (post-VNS))
- The Effect of VNS Therapy on Gastric and Small Intestine Leukocyte Infiltration.(Baseline (pre-VNS) and 4 weeks (post-VNS))
研究者
Linda Nguyen
Clinical Associate Professor, Medicine - Gastroenterology & Hepatology
Stanford University