Controlled Trial of Gastric Electrical Stimulation in Children

NCT07474415 | Completed FDA Device

• 1 other identifier: IRB18-00060
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Gastroparesis; Functional Dyspepsia; Vomiting Syndrome

Keywords

Gastric electrical stimulation; Gastroparesis; Refractory nausea and vomiting; Pediatric motility disorders; Functional dyspepsia

Outcome Measures

Primary Outcomes (1)

• Change in Symptom Monitor Worksheet (SMW) Score

  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 Outcomes (1)

• Change in Maximum Tolerated Volume During Nutrient Drink Test

  Baseline, end of sham phase (Day 5), and end of active stimulation phase (Day 9)

Study Arms (1)

Temporary Gastric Electrical Stimulation (Sham and Active Phases)

EXPERIMENTAL

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

Interventions

Temporary Gastric Electrical Stimulation DEVICE

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.

Also known as: Gastric pacing, Temporary gastric stimulation, Gastric electrical neuromodulation

Temporary Gastric Electrical Stimulation (Sham and Active Phases)

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Nationwide Children's Hospital: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (3)

• Islam S, McLaughlin J, Pierson J, Jolley C, Kedar A, Abell T. Long-term outcomes of gastric electrical stimulation in children with gastroparesis. J Pediatr Surg. 2016 Jan;51(1):67-71. doi: 10.1016/j.jpedsurg.2015.10.015. Epub 2015 Oct 23.

  PMID: 26526207 RESULT

• Ducrotte P, Coffin B, Bonaz B, Fontaine S, Bruley Des Varannes S, Zerbib F, Caiazzo R, Grimaud JC, Mion F, Hadjadj S, Valensi PE, Vuitton L, Charpentier G, Ropert A, Altwegg R, Pouderoux P, Dorval E, Dapoigny M, Duboc H, Benhamou PY, Schmidt A, Donnadieu N, Gourcerol G, Guerci B; ENTERRA Research Group. Gastric Electrical Stimulation Reduces Refractory Vomiting in a Randomized Crossover Trial. Gastroenterology. 2020 Feb;158(3):506-514.e2. doi: 10.1053/j.gastro.2019.10.018. Epub 2019 Oct 21.

  PMID: 31647902 RESULT

• Orsagh-Yentis DK, Ryan K, Hurwitz N, Diefenbach KA, Teich S, Mousa H, Bali N, Vaz K, Yacob D, Di Lorenzo C, Lu PL. Gastric electrical stimulation improves symptoms and need for supplemental nutrition in children with severe nausea and vomiting: A ten-year experience. Neurogastroenterol Motil. 2021 Sep;33(9):e14199. doi: 10.1111/nmo.14199. Epub 2021 Jun 15.

  PMID: 34132458 RESULT

MeSH Terms

Conditions

Gastroparesis; Nausea; Vomiting

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Peter Lu

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants underwent placement of a temporary gastric pacing lead through a nasogastric tube connected to an external gastric electrical stimulator. After placement, all participants entered a sham phase during which the stimulator remained OFF for four days, followed by an active stimulation phase during which the stimulator was turned ON for four days. Participants were blinded to stimulation status and outcomes were compared within participants across phases.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants underwent placement of a temporary gastric pacing lead through a nasogastric tube connected to an external gastric electrical stimulator. After placement, all participants entered a sham phase during which the stimulator remained OFF for four days. This was followed by an active stimulation phase during which the stimulator was turned ON for four days. Participants were blinded to stimulation status throughout the study. Symptom scores and nutrient drink test measurements were obtained at baseline and at the end of each study phase to evaluate changes associated with sham and active stimulation.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 16, 2026
• Study Start: November 25, 2019
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2025
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)