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Completed

NCT Number: NCT03593811

Noninvasive Markers of Functional Nausea in Children

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.

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • children ages 8-17 with functional nausea
  • normal control participants ages 8-17 who have no known gastrointestinal complications

Exclusion criteria

  • Those with claustrophobia who cannot lie still under the SQUID for the length of time required.
  • Normal participants with known intestinal complications
  • Patients with cyclic vomiting syndrome, gastroparesis, malignancy, primary eating disorders, pregnancy, or hyperglycemia
  • Morbid obesity (these patients are presumably unable to lie under the current generation of SQUID devices).
  • Patients with a history of cardiac arrhythmias or taking anticoagulants will be excluded

Treatment and study plan

Questionnaires

Diagnostic Test

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.

4 channel electrogastrogram (EGG)

Diagnostic Test

EGG is a non-invasive technique for recording gastric myoelectrical activity using cutaneous electrodes placed on the abdominal skin over the stomach.

36 channel high resolution electrogastrogram (HR-EGG)

Diagnostic Test

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.

Magnetogastrogram (MGG)

Diagnostic Test

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.

Other names: SQUID magnetometer

Electrocardiogram (EKG)

Diagnostic Test

Electrocardiography is the process of recording the electrical activity of the heart over a period of time using electrodes placed on the skin

ondansetron

Drug

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.

Cyproheptadine Oral Tablet

Drug

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

Primary outcomes

  1. Percentage of Normal Slow Waves (PNSW)

    Time frame: 6 months

    Determine if there are differences in the slow wave activity in healthy versus disease stomach in the pediatric population. The percentage of normal slow waves (PNSW) will be used for comparison. PNSW is computed as the relative time of recording containing slow waves with a dominant frequency between 2-4 cpm from centrally-located EEG and MGG channels.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2018
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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