Functional Dyspepsia, Gastroparesis, Vomiting Syndrome
Conditions
Keywords
Gastric electrical stimulation, Gastroparesis, Refractory nausea and vomiting, Pediatric motility disorders, Functional dyspepsia
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.
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.
Interventions
DEVICETemporary Gastric Electrical Stimulation
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.
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking 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, 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Symptom Monitor Worksheet (SMW) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximum Tolerated Volume During Nutrient Drink Test | Baseline, end of sham phase (Day 5), and end of active stimulation phase (Day 9) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPeter Lu
Nationwide Children's Hospital
Outcome results
None listed