Gastric Electrical Stimulation for Abdominal Pain in Patients With Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Abdominal Pain Score
研究概览
简要总结
Gastroparesis is a disorder characterized by delayed gastric emptying and symptoms including nausea, vomiting, and abdominal pain. Gastric electrical stimulation (GES) using the implanted Enterra™ neurostimulator is FDA-approved to treat nausea and vomiting but its impact on abdominal pain has not been well studied. This study evaluates whether alternative programming parameters of the Enterra™ device can reduce abdominal pain in patients with gastroparesis. Participants with an existing Enterra™ device will be randomized to one of three stimulation settings and followed for assessment of pain, gastrointestinal symptoms, quality of life, and medication use.
详细描述
This is a multicenter, randomized, double-blind, active-controlled, three-arm parallel clinical trial in adults with gastroparesis who have an implanted Enterra™ gastric neurostimulator. All participants will complete a two-week run-in period using their baseline clinical device settings prior to randomization. Participants will then be randomly assigned in a 1:1:1 ratio to one of three gastric electrical stimulation parameter sets: standard nominal parameters (active control), special short-cycle parameters, or modified Enterra parameters delivered continuously. Participants will remain on their assigned blinded settings for eight weeks, during which validated patient-reported measures of abdominal pain, gastroparesis symptoms, quality of life, and pain medication use will be collected. After completion of blinded endpoint assessments, participants may select their preferred settings for an additional eight-week follow-up period. Optional substudy assessments include gastric function testing, inflammatory biomarker analysis, and autonomic nervous system testing.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Device programming assignments are coded and implemented by an independent unblinded technician. Participants and study personnel remain blinded during the randomized treatment phase.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Diagnosed gastroparesis.
- •Implanted Enterra™ device for at least 8 weeks prior to enrollment.
- •Chronic daily abdominal pain of gastric origin lasting more than 2 months.
- •Average pain score ≥4 on a 0-10 scale.
- •Ability to provide informed consent.
排除标准
- •Daily opioid use.
- •Pregnancy or breastfeeding.
- •Abdominal pain not attributed to gastric/visceral origin.
- •Severe constipation or uncontrolled diabetes (HbA1c >10).
- •Other medical conditions that would interfere with study participation.
研究组 & 干预措施
Nominal GES Parameters
Continuous 24-hour gastric electrical stimulation using participants' standard clinically prescribed Enterra™ settings.
干预措施: Enterra™ neurostimulator (Device)
Special Parameter GES
Short-cycle stimulation (0.3 seconds on / 0.2 seconds off; 0.24 ms pulse width; 100 Hz frequency; 4-6 mA amplitude) delivered for one hour every eight hours, with nominal settings used during remaining time.
干预措施: Enterra™ neurostimulator (Device)
Modified Enterra Parameters
Continuous 24-hour stimulation (3 seconds on / 2 seconds off; 0.33 ms pulse width; 14 Hz frequency; 15-20 mA amplitude).
干预措施: Enterra™ neurostimulator (Device)
结局指标
主要结局
Change in Abdominal Pain Score
时间窗: Baseline to 8 weeks after randomization.
Change from baseline in seven-day average of daily worst abdominal pain score measured using an 11-point Numeric Rating Scale (0 = no pain, 10 = worst possible pain).
次要结局
- Change in Brief Pain Inventory Score(Baseline to 8 weeks after randomization.)
- Change in Gastroparesis Cardinal Symptom Index score(From baseline to 8 weeks after randomization)
- Change in Pain Medications(During the 8-week randomized treatment period.)
- Percent Reduction in Pain Score(Baseline to 8 weeks.)
- Change in Inflammatory Cytokines(Baseline to 8 weeks.)
- Change in Autonomic Function(Baseline to 8 weeks)
- Change in Gastric Electrophysiology(baseline to 8 weeks)
研究者
Thomas Abell
Arthur M Schoen MD Chair in Gastroenterology
University of Louisville