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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls | Active Comparator | 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. |
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| Non-nauseated | Active Comparator | 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. |
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| Mildly nauseated | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Bradshaw, Ph.D. | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D017294 | Ondansetron |
| D003533 | Cyproheptadine |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Moderately nauseated | Active Comparator | 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. |
|
| Severely nauseated | Active Comparator | 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. |
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| 4 channel electrogastrogram (EGG) | Diagnostic Test | EGG is a non-invasive technique for recording gastric myoelectrical activity using cutaneous electrodes placed on the abdominal skin over the stomach. |
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| 36 channel high resolution electrogastrogram (HR-EGG) | Diagnostic Test | 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. |
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| Magnetogastrogram (MGG) | Diagnostic Test | 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. |
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| Electrocardiogram (EKG) | Diagnostic Test | Electrocardiography is the process of recording the electrical activity of the heart over a period of time using electrodes placed on the skin |
|
| Ondansetron | Drug | 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. |
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| Cyproheptadine Oral Tablet | Drug | 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 |
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| D004568 | Electrodiagnosis |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D011083 | Polycyclic Compounds |