Noninvasive Markers of Functional Nausea in Children

NCT03593811 | Completed Early Phase 1 FDA Device

• 1 other identifier: 162035
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of Normal Slow Waves (PNSW)

  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.

  6 months

Study Arms (5)

Healthy Controls

ACTIVE COMPARATOR

Healthy Volunteers with no known gastrointestinal complications will be given questionnaires and testing by electrogastrogram (EGG) and/or magnetogastrogram (MGG) after an overnight fast to determine nausea parameters. They will also have a electrocardiogram (EKG) and do some testing after being fed a protein bar.

Diagnostic Test: Questionnaires; Diagnostic Test: 4 channel electrogastrogram (EGG); Diagnostic Test: 36 channel high resolution electrogastrogram (HR-EGG); Diagnostic Test: Magnetogastrogram (MGG); Diagnostic Test: Electrocardiogram (EKG)

Non-nauseated

ACTIVE COMPARATOR

Functional nausea patients with a score of 0-2 on the BARF (BAxter Retching Faces) scale will be given questionnaires and testing by EGG and/or MGG after an overnight fast to determine nausea parameters. They will also have a EKG and do some testing after being fed a protein bar.

Diagnostic Test: Questionnaires; Diagnostic Test: 4 channel electrogastrogram (EGG); Diagnostic Test: 36 channel high resolution electrogastrogram (HR-EGG); Diagnostic Test: Magnetogastrogram (MGG); Diagnostic Test: Electrocardiogram (EKG)

Mildly nauseated

ACTIVE COMPARATOR

Functional nausea patients with a score of 3-4 on the BARF (BAxter Retching Faces) scale will be given questionnaires and testing by EGG and/or MGG after an overnight fast to determine nausea parameters. They will also have a EKG and do some testing after being fed a protein bar.

Diagnostic Test: Questionnaires; Diagnostic Test: 4 channel electrogastrogram (EGG); Diagnostic Test: 36 channel high resolution electrogastrogram (HR-EGG); Diagnostic Test: Magnetogastrogram (MGG); Diagnostic Test: Electrocardiogram (EKG)

Moderately nauseated

ACTIVE COMPARATOR

Functional nausea patients with a score of 5-6 on the BARF (BAxter Retching Faces) scale will be given questionnaires and testing by EGG and/or MGG after an overnight fast to determine nausea parameters. They will also have a EKG and do some testing after being fed a protein bar.

Diagnostic Test: Questionnaires; Diagnostic Test: 4 channel electrogastrogram (EGG); Diagnostic Test: 36 channel high resolution electrogastrogram (HR-EGG); Diagnostic Test: Magnetogastrogram (MGG); Diagnostic Test: Electrocardiogram (EKG)

Severely nauseated

ACTIVE COMPARATOR

Functional nausea patients with a score of 7-9 on the BARF (BAxter Retching Faces) scale will be given questionnaires and testing by EGG and/or MGG after an overnight fast to determine nausea parameters. They will also have a EKG and do some testing after being fed a protein bar. Some patients will also be tested after receiving a one time dose of a 4mg or 8mg dependent upon age disintegrating tablet of ondansetron followed by a 2 day washout period prior to testing again after a 5 day maintenance dose of oral cyproheptadine 4mg twice a day.

Diagnostic Test: Questionnaires; Diagnostic Test: 4 channel electrogastrogram (EGG); Diagnostic Test: 36 channel high resolution electrogastrogram (HR-EGG); Diagnostic Test: Magnetogastrogram (MGG); Diagnostic Test: Electrocardiogram (EKG); Drug: Ondansetron; Drug: Cyproheptadine Oral Tablet

Interventions

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.

Healthy Controls; Mildly nauseated; Moderately nauseated; Non-nauseated; Severely nauseated

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.

Healthy Controls; Mildly nauseated; Moderately nauseated; Non-nauseated; Severely nauseated

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.

Healthy Controls; Mildly nauseated; Moderately nauseated; Non-nauseated; Severely nauseated

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.

Also known as: SQUID magnetometer

Healthy Controls; Mildly nauseated; Moderately nauseated; Non-nauseated; Severely nauseated

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

Healthy Controls; Mildly nauseated; Moderately nauseated; Non-nauseated; Severely nauseated

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.

Severely nauseated

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

Severely nauseated

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Nausea

Interventions

Electrocardiography; Ondansetron; Cyproheptadine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Polycyclic Compounds

Study Officials

• Alan Bradshaw, Ph.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2018
• First Posted: July 20, 2018
• Study Start: August 3, 2018
• Primary Completion: April 2, 2021
• Study Completion: April 2, 2021
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)