Controlled Trial of Gastric Electrical Stimulation in Children

March 11, 2026 updated by: Peter Lu, Nationwide Children's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Other Names:
  • Gastric pacing
  • Temporary gastric stimulation
  • Gastric electrical neuromodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Symptom Monitor Worksheet (SMW) Score
Time Frame: 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.
Baseline, Day 5 (end of sham phase), and Day 9 (end of active stimulation phase)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Maximum Tolerated Volume During Nutrient Drink Test
Time Frame: Baseline, end of sham phase (Day 5), and end of active stimulation phase (Day 9)
The nutrient drink test measures tolerance to oral nutrient intake. Participants consumed a standardized nutrient liquid until reaching maximum tolerated fullness. The maximum tolerated volume (mL) was recorded 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 gastric tolerance associated with gastric electrical stimulation.
Baseline, end of sham phase (Day 5), and end of active stimulation phase (Day 9)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Peter Lu, Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2019

Primary Completion (Actual)

October 21, 2024

Study Completion (Actual)

October 21, 2025

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB18-00060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly shared due to privacy considerations and the small sample size.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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