Clinical Trial

Controlled Trial of Gastric Electrical Stimulation in Children

Completed
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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.
Trial Details
NCT Number NCT07474415
Lead Sponsor Nationwide Children's Hospital
Conditions Gastroparesis, Functional Dyspepsia, Vomiting Syndrome
Enrollment 30 participants
Start Date 2019-11-25
Primary Completion 2024-10-21 (estimated)
Study Completion 2025-10-21 (estimated)
Updated on ClinicalTrials.gov 2026-03-16