NauseaEarly Phase 1NCT03593811
Noninvasive Markers of Functional Nausea in Children
A Early Phase 1 study testing Questionnaires, 4 channel electrogastrogram (EGG) and 36 channel high resolution electrogastrogram (HR-EGG) in people with Nausea, run by Vanderbilt University Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Nausea
- What is being tested?
- Questionnaires, 4 channel electrogastrogram (EGG) and 36 channel high resolution electrogastrogram (HR-EGG)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2018to 2 Apr 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children ages 8-17 with functional nausea
- normal control participants ages 8-17 who have no known gastrointestinal complications
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
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.
Read the 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.
- Conditions
- Nausea
- Being tested
- Questionnaires, 4 channel electrogastrogram (EGG), 36 channel high resolution electrogastrogram (HR-EGG), Magnetogastrogram (MGG), Electrocardiogram (EKG)
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesDiagnostic 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.
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.
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.
Magnetogastrogram (MGG)Diagnostic test
Also called SQUID magnetometer
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)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
OndansetronDrug
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 TabletDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
| 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. Receives: 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) |
| 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. Receives: 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) |
| 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. Receives: 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) |
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start3 Aug 2018
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Bradshaw, Vanderbilt University Medical Center
- Investigators
- Alan Bradshaw, Ph.D., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593811
- Sponsor's protocol ID
- 162035
- Status last verified
- Apr 2026
- First submitted
- 19 Jun 2018
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Markers of Functional Nausea in Children
- ClinicalTrials.gov ID
- NCT03593811
- Acronym / sponsor ID
- 162035
- Conditions
- Nausea
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Active comparator | 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)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. |
| Non-nauseated | Active comparator | 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)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. |
| Mildly nauseated | Active comparator | 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)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. |
| Moderately nauseated | Active comparator | 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)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 | 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 TabletFunctional 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. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children ages 8-17 with functional nausea
- normal control participants ages 8-17 who have no known gastrointestinal complications
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesPatients 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 | Healthy Controls, Mildly nauseated, Moderately nauseated, Non-nauseated, Severely nauseated |
| 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 | Healthy Controls, Mildly nauseated, Moderately nauseated, Non-nauseated, Severely nauseated |
| 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 | Healthy Controls, Mildly nauseated, Moderately nauseated, Non-nauseated, Severely nauseated |
| Magnetogastrogram (MGG)Also: SQUID magnetometerMGG 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 test | Healthy Controls, Mildly nauseated, Moderately nauseated, Non-nauseated, Severely nauseated |
| 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 | Diagnostic test | Healthy Controls, Mildly nauseated, Moderately nauseated, Non-nauseated, Severely nauseated |
| OndansetronPatients 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 | Severely nauseated |
| Cyproheptadine Oral TabletPatients 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 | Drug | Severely nauseated |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan Bradshaw, Ph.D. principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Questionnaires, 4 channel electrogastrogram (EGG) and 36 channel high resolution electrogastrogram (HR-EGG) in people with Nausea, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Normal Slow Waves (PNSW) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.