Noninvasive Markers of Functional Nausea in Children

• ClinicalTrials.gov Identifier: NCT03593811
• Recruitment Status: Enrolling by invitation
• First Posted: July 20, 2018
• Last Update Posted: April 12, 2021
• Sponsor: Vanderbilt University Medical Center
• Information provided by (Responsible Party): Alan Bradshaw, Vanderbilt University Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Nausea	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	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 130 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Noninvasive Markers of Functional Nausea in Children
• Actual Study Start Date: August 3, 2018
• Estimated Primary Completion Date: September 2023
• Estimated Study Completion Date: December 2023

Arms and Interventions

Arm	Intervention/treatment
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 Name: 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 Name: 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 Name: 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 Name: 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 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; 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 Name: 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 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

Outcome Measures

Primary Outcome Measures :

1. Percentage of Normal Slow Waves (PNSW) [ Time Frame: 6 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37212

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

• Principal Investigator: Alan Bradshaw, Ph.D.; Vanderbilt University

More Information

• Responsible Party: Alan Bradshaw, Principal Investigator, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03593811
• Other Study ID Numbers: 162035
• First Posted: July 20, 2018
• Last Update Posted: April 12, 2021
• Last Verified: April 2021

• 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

Additional relevant MeSH terms:

Nausea; Signs and Symptoms, Digestive; Cyproheptadine; Ondansetron; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Antipruritics; Dermatologic Agents; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Anti-Anxiety Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Anti-Allergic Agents