Controlled Trial of Gastric Electrical Stimulation in Children
Key facts
- Who runs it
- Nationwide Children's Hospital
- Where
- Columbus, United StatesSee the site
- Trial code
- Status
- Completed
- People taking part
- 30 people enrolled
- Started
- 25 Nov 2019
- Ended
- 21 Oct 2025
- Type of study
- Interventional
- Treatments tested
- Temporary Gastric Electrical Stimulation
- Record updated
- 16 March 2026
Who can take part
- Age
- Up to 21 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Diagnosis of an eating disorder
- Psychiatric condition deemed by the medical team to pose a safety concern for study participation
- Mechanical obstruction of the gastrointestinal tract
- Inability of the participant to communicate symptoms
- Inability of the participant or parent/guardian to read or speak English
Where in United States
- Nationwide Children's HospitalColumbus, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- Temporary Gastric Electrical Stimulation (Sham and Active Phases)Treatment being tested
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.
Treatment: Temporary Gastric Electrical Stimulation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective, Controlled Trial of Gastric Electrical Stimulation in Children With Nausea and Vomiting
- Publications
- Gastric electrical stimulation for children with refractory nausea and vomiting: A sham-controlled trial.Journal of pediatric gastroenterology and nutrition, 2026
- Record updated
- 16 March 2026