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Controlled Trial of Gastric Electrical Stimulation in Children

NCT07474415 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • Peter Lu · Nationwide Children's Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2024-10-21
Completion
2025-10-21
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07474415 on ClinicalTrials.gov