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Noninvasive Markers of Functional Nausea in Children

Primary Purpose

Nausea

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Questionnaires
4 channel electrogastrogram (EGG)
36 channel high resolution electrogastrogram (HR-EGG)
Magnetogastrogram (MGG)
Electrocardiogram (EKG)
Ondansetron
Cyproheptadine Oral Tablet
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nausea

Eligibility Criteria

8 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Healthy Controls

Non-nauseated

Mildly nauseated

Moderately nauseated

Severely nauseated

Arm Description

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 19, 2018
Last Updated
May 1, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03593811
Brief Title
Noninvasive Markers of Functional Nausea in Children
Official Title
Noninvasive Markers of Functional Nausea in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 3, 2018 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Controls
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Non-nauseated
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mildly nauseated
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Moderately nauseated
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Severely nauseated
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Questionnaires
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
4 channel electrogastrogram (EGG)
Intervention Description
EGG is a non-invasive technique for recording gastric myoelectrical activity using cutaneous electrodes placed on the abdominal skin over the stomach.
Intervention Type
Diagnostic Test
Intervention Name(s)
36 channel high resolution electrogastrogram (HR-EGG)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetogastrogram (MGG)
Other Intervention Name(s)
SQUID magnetometer
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Electrocardiogram (EKG)
Intervention Description
Electrocardiography is the process of recording the electrical activity of the heart over a period of time using electrodes placed on the skin
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cyproheptadine Oral Tablet
Intervention Description
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 Outcome Measure Information:
Title
Percentage of Normal Slow Waves (PNSW)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Bradshaw, Ph.D.
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

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Noninvasive Markers of Functional Nausea in Children

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