GastroparesisNCT07474415
Controlled Trial of Gastric Electrical Stimulation in Children
A study testing Temporary Gastric Electrical Stimulation in people with Gastroparesis and Functional Dyspepsia, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Gastroparesis, Functional Dyspepsia, Vomiting Syndrome
- What is being tested?
- Temporary Gastric Electrical Stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2019to 21 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastroparesis, Functional Dyspepsia, Vomiting Syndrome
- Being tested
- Temporary Gastric Electrical Stimulation
- Keywords
- Gastric electrical stimulation, Gastroparesis, Refractory nausea and vomiting, Pediatric motility disorders, Functional dyspepsia
- Medical subject headings
- Gastroparesis, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary Gastric Electrical StimulationDevice
Also called Gastric pacing, Temporary gastric stimulation, Gastric electrical neuromodulation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Temporary Gastric Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, end of sham phase (Day 5), and end of active stimulation phase (Day 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start25 Nov 2019
- Primary completion21 Oct 2024
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lu, Nationwide Children's Hospital
- Investigators
- Peter Lu, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474415
- Sponsor's protocol ID
- IRB18-00060
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be publicly shared due to privacy considerations and the small sample size.
Publications
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.
PubMed 26526207Ducrotte 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.
PubMed 31647902Orsagh-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.
PubMed 34132458Hawa K, Castillo-Leon E, Sanchez RE, Usman AP, Diefenbach K, Van Diest AK, Puri NB, Vaz K, Yacob D, Lorenzo CD, Lu PL. Gastric electrical stimulation for children with refractory nausea and vomiting: A sham-controlled trial. J Pediatr Gastroenterol Nutr. 2026 Sep 14. doi: 10.1002/jpn3.70583. Online ahead of print.
PubMed 42736046
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled Trial of Gastric Electrical Stimulation in Children With Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT07474415
- Acronym / sponsor ID
- IRB18-00060
- Conditions
- Gastroparesis, Functional Dyspepsia, Vomiting Syndrome
- Keywords
- Gastric electrical stimulation, Gastroparesis, Refractory nausea and vomiting, Pediatric motility disorders, Functional dyspepsia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Temporary Gastric Electrical Stimulation (Sham and Active Phases) | Experimental | Device: Temporary Gastric Electrical StimulationParticipants 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. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporary Gastric Electrical StimulationAlso: Gastric pacing, Temporary gastric stimulation, Gastric electrical neuromodulationParticipants 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. | Device | Temporary Gastric Electrical Stimulation (Sham and Active Phases) |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Results publication: PubMed 26526207Islam 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.
- Results publication: PubMed 31647902Ducrotte 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.
- Results publication: PubMed 34132458Orsagh-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.
- Derived from this study: PubMed 42736046Hawa K, Castillo-Leon E, Sanchez RE, Usman AP, Diefenbach K, Van Diest AK, Puri NB, Vaz K, Yacob D, Lorenzo CD, Lu PL. Gastric electrical stimulation for children with refractory nausea and vomiting: A sham-controlled trial. J Pediatr Gastroenterol Nutr. 2026 Sep 14. doi: 10.1002/jpn3.70583. Online ahead of print.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to privacy considerations and the small sample size.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Lu principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary Gastric Electrical Stimulation in people with Gastroparesis and Functional Dyspepsia, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Symptom Monitor Worksheet (SMW) Score (time frame: Baseline, Day 5 (end of sham phase), and Day 9 (end of active stimulation phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07474415, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.