NCT07474415

Controlled Trial of Gastric Electrical Stimulation in Children

Prospective, Controlled Trial of Gastric Electrical Stimulation in Children With Nausea and Vomiting

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Nationwide Children's Hospital · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastroparesis
• Functional Dyspepsia
• Vomiting Syndrome

Interventions

Type	Name	Description
DEVICE	Temporary Gastric Electrical Stimulation	Participants underwent placement of a temporary gastric pacing lead through a nasogastric tube connected to an external gastric electrical stimulator. The device was used to deliver gastric electrical stimulation during the active phase of the study. During the sham phase the device remained OFF, while during the active phase electrical stimulation was delivered to the stomach. The intervention was used to evaluate the effects of gastric electrical stimulation on symptoms of nausea and vomiting and tolerance to oral nutrient intake in children with refractory symptoms.

Timeline

• Start date: 2019-11-25
• Primary completion: 2024-10-21
• Completion: 2025-10-21
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study