Controlled Trial of Gastric Electrical Stimulation in Children

Completed · Not applicable · Has a placebo group

Conditions studied: Gastroparesis, Functional Dyspepsia, Vomiting Syndrome

In brief

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.

Key facts

Study ID

NCT07474415

Run by

Nationwide Children's Hospital

People needed

30

Starts

2019-11-25

Expected to finish

2025-10-21

Last updated by the study team

2026-03-16

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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