Noninvasive Markers of Functional Nausea in Children

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.

Conditions

• Nausea

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

Sponsors & Collaborators

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Alan Bradshaw, Ph.D. · Vanderbilt University

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

8 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-08-03

Primary Completion

2021-04-02

Completion

2021-04-02

FDA Device

Yes

Countries

• United States

Study Locations