Noninvasive Markers of Functional Nausea in Children

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

August 3, 2018

Primary Completion Date

March 31, 2026

Study Completion Date

August 31, 2026

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

Trial Locations (1)

37212

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
lead

Vanderbilt University Medical Center

OTHER