Purpose

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.

Condition

Eligibility

Eligible Ages
Between 8 Years and 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Healthy Controls
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
    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.
    Other names:
    • SQUID magnetometer
  • 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
Active Comparator
Non-nauseated
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
    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.
    Other names:
    • SQUID magnetometer
  • 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
Active Comparator
Mildly nauseated
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
    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.
    Other names:
    • SQUID magnetometer
  • 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
Active Comparator
Moderately nauseated
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
    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.
    Other names:
    • SQUID magnetometer
  • 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
Active Comparator
Severely nauseated
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 8mg disintegrating tablet of ondansetron followed by a 2 day washout period prior to testing again after a 5 day maintenance dose of oral cyproheptadine (0.04-0.62 mg/kg/day).
  • 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.
    Other names:
    • SQUID magnetometer
  • 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 8 mg ondansetron 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 0.04-0.62 mg/kg/day to examine the effects of pharmacological alteration of specific nausea pathways on gastric slow wave patterns in functional nausea patients

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37212
Contact:
Melissa Beavers
615-936-7017
melissa.beavers@vumc.org

More Details

NCT ID
NCT03593811
Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Melissa Beavers
615-936-7017
melissa.beavers@vumc.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.