Noninvasive Markers of Functional Nausea in Children

Noninvasive Markers of Functional Nausea in Children

Sponsors

Lead Sponsor: Vanderbilt University Medical Center

Source Vanderbilt University Medical Center
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.

Overall Status Enrolling by invitation
Start Date August 3, 2018
Completion Date December 2023
Primary Completion Date September 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Normal Slow Waves (PNSW) 6 months
Enrollment 130
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Questionnaires

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: 4 channel electrogastrogram (EGG)

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: 36 channel high resolution electrogastrogram (HR-EGG)

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: Magnetogastrogram (MGG)

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.

Other Name: SQUID magnetometer

Intervention Type: Diagnostic Test

Intervention Name: Electrocardiogram (EKG)

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: Ondansetron

Description: 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.

Arm Group Label: Severely nauseated

Intervention Type: Drug

Intervention Name: Cyproheptadine Oral Tablet

Description: 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

Arm Group Label: Severely nauseated

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

Gender: All

Minimum Age: 8 Years

Maximum Age: 17 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Alan Bradshaw, Ph.D. Principal Investigator Vanderbilt University
Location
Facility: Vanderbilt University Medical Center
Location Countries

United States

Verification Date

April 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Vanderbilt University Medical Center

Investigator Full Name: Alan Bradshaw

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 5
Arm Group

Label: Healthy Controls

Type: Active Comparator

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.

Label: Non-nauseated

Type: Active Comparator

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.

Label: Mildly nauseated

Type: Active Comparator

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.

Label: Moderately nauseated

Type: Active Comparator

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.

Label: Severely nauseated

Type: Active Comparator

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 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).

Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov