Noninvasive Markers of Functional Nausea in Children

Nausea Clinical Trial

Official title:

Noninvasive Markers of Functional Nausea in Children

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03593811
• Other study ID #: 162035
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 3, 2018
• Est. completion date: March 2025

Study information

• Verified date: May 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 130
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea

Intervention

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.
• 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.
• 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.
• 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.
• 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.
• 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

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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