Prospective, Controlled Trial of Gastric Electrical Stimulation in Children With Nausea and Vomiting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Symptom Monitor Worksheet (SMW) Score
研究概览
简要总结
This study evaluates whether gastric electrical stimulation (GES) improves symptoms in children with severe nausea and vomiting that have not responded to standard treatments. GES is a therapy that delivers small electrical pulses to the stomach to help improve stomach function and reduce symptoms. In this study, children underwent temporary gastric electrical stimulation using a pacing lead placed through a nasogastric tube. The stimulation device was turned OFF for four days and then ON for four days, while participants remained blinded to the stimulation status. Symptoms and tolerance to oral nutrient intake were measured at baseline and during each study phase. The goal of the study was to determine whether active stimulation improves symptoms and nutrient intake compared with the sham period.
详细描述
Children and adolescents with severe nausea and vomiting that do not respond to medical therapy represent a challenging clinical population. Gastric electrical stimulation (GES) has been used as a treatment option for patients with refractory symptoms, but controlled trials in children are limited.
This single-blinded, sham-controlled clinical trial evaluated the short-term effects of temporary gastric electrical stimulation in pediatric patients with refractory nausea and vomiting. Participants underwent placement of a temporary pacing lead through a nasogastric tube connected to an external stimulator. After placement, the stimulator remained OFF for the first four days followed by ON for the next four days. Participants were blinded to the stimulation status.
Baseline data included demographic characteristics, medical history, nutritional status, and symptom assessments using the Symptom Monitor Worksheet (SMW). Participants also completed a nutrient drink test to evaluate tolerance to oral intake. Symptom scores and nutrient drink test volumes were reassessed at the end of each study phase.
The primary objective of the study was to evaluate changes in nausea and vomiting symptoms during sham and active stimulation phases. Secondary objectives included evaluating changes in symptom severity and frequency across gastrointestinal symptoms and assessing tolerance to nutrient intake during the study periods.
This study aims to better understand whether gastric electrical stimulation may improve symptoms and oral intake in children with refractory nausea and vomiting and to inform future therapeutic approaches for this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Participants underwent placement of a temporary gastric pacing lead through a nasogastric tube connected to an external gastric electrical stimulator. After placement, all participants entered a sham phase during which the stimulator remained OFF for four days, followed by an active stimulation phase during which the stimulator was turned ON for four days. Participants were blinded to stimulation status and outcomes were compared within participants across phases.
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age < 21 years
- •History of chronic nausea and vomiting refractory to medical therapy for at least 12 months
- •Symptoms severe enough to impact overall condition (e.g., weight loss or need for dietary modification)
- •Ability of participant and/or parent/guardian to provide informed consent/assent
排除标准
- •Mechanical obstruction of the gastrointestinal tract.
- •Diagnosis of an eating disorder
- •Psychiatric condition deemed by the medical team to pose a safety concern for study participation
- •Inability of the participant to communicate symptoms
- •Inability of the participant or parent/guardian to read or speak English
研究组 & 干预措施
Temporary Gastric Electrical Stimulation (Sham and Active Phases)
Participants undergo placement of a temporary gastric pacing lead connected to an external stimulator. The stimulator remains OFF for the first four days (sham phase) and is then turned ON for the following four days (active stimulation phase). Participants are blinded to stimulation status.
干预措施: Temporary Gastric Electrical Stimulation (Device)
结局指标
主要结局
Change in Symptom Monitor Worksheet (SMW) Score
时间窗: Baseline, Day 5 (end of sham phase), and Day 9 (end of active stimulation phase)
The Symptom Monitor Worksheet (SMW) is used to assess frequency and severity of upper gastrointestinal symptoms, including nausea and vomiting. SMW scores were collected at baseline, at the end of the sham phase (stimulator OFF), and at the end of the active stimulation phase (stimulator ON) to evaluate changes in symptoms during gastric electrical stimulation.
次要结局
- Change in Maximum Tolerated Volume During Nutrient Drink Test(Baseline, end of sham phase (Day 5), and end of active stimulation phase (Day 9))
研究者
Peter Lu
MD
Nationwide Children's Hospital