NCT03593811

Noninvasive Markers of Functional Nausea in Children

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The researchers propose to study how functional nausea in adolescents may be characterized noninvasively by the use of multichannel electrogastrogram (EGG) and magnetogastrogram (MGG) recordings.

Detailed description

5/23/25. Study record updated to reflect Early Phase I trial as opposed to "N/A". The main aims were to develop a mathematical model of FN, correlate functional differences in slow waves in FN patients using modeling and experimental approaches, and to characterize biophysical, clinical, and psychosocial phenotypes of FN using newly developed diagnostic devices of EGG/MGG. Functional nausea (FN) is a GI disorder that affects millions of Americans, particularly adolescents, but diagnoses remain largely exclusionary relying on symptomology with an otherwise normal diagnostic workup. Successful completion of the project could contribute to understanding the altered physiology of functional nausea (FN), to stratification of FN patients according to physiological and/or psychological phenotypes, to improve diagnosis and provide objective measures of nausea and to inform and guide treatment options. The analysis of slow wave activity represents the first physiologically-quantifiable noninvasive assessment method for pathological processes associated with functional nausea in adolescents.

Conditions

• Nausea

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Questionnaires	Patients will be provide answers to one or more of the following: Rome III criteria, BARF pictorial scale, Nausea Severity scale, Children's Somatization Inventory, State-Trait Anxiety Inventory, Functional Disability Inventory, and the Nausea Interference Scale.
DIAGNOSTIC_TEST	4 channel electrogastrogram (EGG)	EGG is a non-invasive technique for recording gastric myoelectrical activity using cutaneous electrodes placed on the abdominal skin over the stomach.
DIAGNOSTIC_TEST	36 channel high resolution electrogastrogram (HR-EGG)	HR- EGG utilizes an array of electrodes to estimate the direction and speed of gastric slow-waves using cutaneous electrodes placed on the abdominal skin over the stomach.
DIAGNOSTIC_TEST	Magnetogastrogram (MGG)	MGG measures spatiotemporal properties of magnetic fields from the gastric slow wave and allows characterization of the propagation of the gastric slow wave in addition to evaluation of its frequency and power distribution.
DIAGNOSTIC_TEST	Electrocardiogram (EKG)	Electrocardiography is the process of recording the electrical activity of the heart over a period of time using electrodes placed on the skin
DRUG	Ondansetron	Patients will be administered 4mg or 8 mg ondansetron dependent upon age in order to assess the effect of ondansetron on the symptoms of nausea and changes in slow wave dysrhythmias.
DRUG	Cyproheptadine Oral Tablet	Patients will be prescribed a 5 day maintenance dose of cyproheptadine using dosing 4mg twice a day to examine the effects of pharmacological alteration of specific nausea pathways on gastric slow wave patterns in functional nausea patients

Timeline

• Start date: 2018-08-03
• Primary completion: 2026-03-31
• Completion: 2026-08-31
• First posted: 2018-07-20
• Last updated: 2025-05-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study