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ACTIVE NOT RECRUITING
NCT03593811
EARLY_PHASE1

Noninvasive Markers of Functional Nausea in Children

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

8 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2018-08-03

Completion Date

2026-08-31

Last Updated

2025-05-30

Healthy Volunteers

Yes

Conditions

Interventions

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

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States