Nausea
Conditions
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
5/23/25. Study record updated to reflect Early Phase I trial as opposed to N/A. The main aims were to develop a mathematical model of FN, correlate functional differences in slow waves in FN patients using modeling and experimental approaches, and to characterize biophysical, clinical, and psychosocial phenotypes of FN using newly developed diagnostic devices of EGG/MGG. 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.
Interventions
DIAGNOSTIC_TESTQuestionnaires
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_TEST4 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_TEST36 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_TESTMagnetogastrogram (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.
DIAGNOSTIC_TESTElectrocardiogram (EKG)
Electrocardiography is the process of recording the electrical activity of the heart over a period of time using electrodes placed on the skin
DRUGOndansetron
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.
DRUGCyproheptadine 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
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Normal Slow Waves (PNSW) | 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. |
Countries
United States
Outcome results
None listed