Noninvasive Diagnostic Tests for Nausea

Age: < 18

Sex: Any

Trial Phase: Phase < 1

Sponsor: Vanderbilt University Medical Center

Must not be taking: Anticoagulants

Disqualifiers: Claustrophobia, Intestinal complications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to diagnose functional nausea in adolescents without invasive tests. Researchers will use noninvasive tools such as heart and stomach monitoring, including the 36-channel high-resolution electrogastrogram (HR-EGG), 4-channel electrogastrogram (EGG), and magnetogastrogram (MGG), along with several questionnaires, to understand how nausea affects the body. Participants are grouped based on the severity of their nausea, including some who are healthy and do not experience nausea. Children aged 8-17 who frequently experience nausea or are healthy without stomach issues may be suitable for this study. As an Early Phase 1 trial, this research focuses on understanding how these diagnostic tools function in people, offering participants a chance to contribute to groundbreaking methods in nausea diagnosis.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking anticoagulants, you will not be eligible to participate.

What prior data suggests that these noninvasive diagnostic tests are safe for adolescents?

Research has shown that the tools used in this study, such as the electrogastrogram (EGG) and magnetogastrogram (MGG), are noninvasive and generally safe. The 36-channel high-resolution electrogastrogram (HR-EGG) and the 4-channel EGG record stomach electrical activity using electrodes placed on the skin. Previous studies have found these methods to be well-tolerated, with no major safety concerns.

The magnetogastrogram (MGG) captures magnetic signals from the stomach and has been used safely in research. Past studies have not reported any significant side effects with these devices.

For participants with severe nausea, ondansetron and cyproheptadine are also used. Ondansetron, a common medication for nausea, is generally safe, though it can occasionally affect heart rhythm. Cyproheptadine is used to boost appetite and is considered safe, as supported by a systematic review. Some side effects, like drowsiness or dry mouth, can occur but are usually manageable.

Overall, these treatments have been well-tolerated with few adverse events in past use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these noninvasive diagnostic tests for nausea because they offer a fresh approach to understanding and treating this common but often tricky condition. Unlike current treatments that focus mainly on medication to relieve symptoms, these tests use innovative technologies like high-resolution electrogastrogram (HR-EGG) and magnetogastrogram (MGG) to get a detailed picture of stomach activity. This could lead to more personalized treatment plans. Additionally, the tests are noninvasive and aim to provide insights without the need for invasive procedures, which is a significant advantage for patient comfort and safety. By identifying nausea parameters more accurately, these tests could pave the way for better-targeted treatments in the future.

What evidence suggests that these noninvasive diagnostic tests are effective for characterizing nausea?

Research has shown that two tools, the 36-channel high-resolution electrogastrogram (HR-EGG) and the magnetogastrogram (MGG), hold promise for detecting patterns related to functional nausea. HR-EGG uses sensors to track slow waves in the stomach, identifying problems with stomach function. MGG detects tiny electrical signals in the stomach, offering clues about the causes of nausea. Studies indicate that using both methods together can reveal important signs of nausea in children. In this trial, participants in different arms will undergo testing with these tools to assess nausea parameters. Additionally, some participants in the "Severely nauseated" arm will receive ondansetron, which has proven effective in reducing nausea in various conditions; some studies showed that up to 96.3% of patients did not experience nausea. Cyproheptadine, also administered in this arm, has shown promise with high success rates in treating vomiting related to cyclic vomiting syndrome. ^{1 3 5 6 7}

Who Is on the Research Team?

Alan Bradshaw, Ph.D.

Principal Investigator

Vanderbilt University

Are You a Good Fit for This Trial?

This trial is for children aged 8-17 who either experience functional nausea or are healthy controls without gastrointestinal issues. It excludes those with claustrophobia, cardiac arrhythmias, severe obesity, cyclic vomiting syndrome, gastroparesis, cancer, eating disorders, pregnancy or hyperglycemia.

Inclusion Criteria

My child, aged 8-17, frequently experiences nausea without a clear cause.

I am between 8-17 years old and do not have any known stomach or intestine problems.

Exclusion Criteria

I do not have a history of heart rhythm problems and am not on blood thinners.

You are very overweight and may not fit properly in the equipment used for the study.

I do not have cyclic vomiting, gastroparesis, cancer, eating disorders, am not pregnant, and do not have high blood sugar.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Participants undergo EGG and MGG testing, questionnaires, and EKG after an overnight fast. Testing includes response to a protein bar and, for some, ondansetron and cyproheptadine administration.

6 months

Follow-up

Participants are monitored for changes in nausea parameters and slow wave activity.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 36 channel high resolution electrogastrogram (HR-EGG)
• 4 channel electrogastrogram (EGG)
• Cyproheptadine Oral Tablet
• Electrocardiogram (EKG)
• Magnetogastrogram (MGG)
• Ondansetron
• Questionnaires

Trial Overview The study aims to identify noninvasive markers of functional nausea using questionnaires and various recording techniques like EGG and MGG. Medications Ondansetron and Cyproheptadine will also be evaluated in this pediatric population.

How Is the Trial Designed?

Group I: Moderately nauseated Active Control 5 Interventions

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.

Group II: Severely nauseated Active Control 7 Interventions

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.

Group III: Healthy Controls Active Control 5 Interventions

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.

Group IV: Non-nauseated Active Control 5 Interventions

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.

Group V: Mildly nauseated Active Control 5 Interventions

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.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9678406/

a clinical marker for pediatric chronic nausea - PMC Our study demonstrates that multichannel MGG used in conjunction with custom HR-EGG detects key pathological signatures of functional nausea in children.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5474202/

A Novel, Noninvasive Method for Determining Gastric Slow ... In this paper we present the high-resolution (HR) EGG, which utilizes an array of electrodes to estimate the direction and speed of gastric slow-waves. The ...

3. ghadvances.org ghadvances.org/article/S2772-5723(25)00015-9/fulltext

Noninvasive Quantification of Nausea Severity in Pediatric ... We hypothesize that high-resolution electrogastrogram (HR-EGG) spatiotemporal gastric slow wave parameters, reflective of known mechanisms of gastric uncoupling ...

4. cghjournal.org cghjournal.org/article/S1542-3565(19)30429-X/fulltext

Spatial Patterns From High-Resolution ... Cutaneous high-resolution electrogastrography (HR-EGG) is a non-invasive method that can detect spatial features of the gastric slow wave. We ...

5. mdpi.com mdpi.com/1424-8220/22/22/8616

Electrogastrogram-Derived Features for Automated ... We introduce an automated procedure comprising statistical analysis and machine learning techniques for EGG-based nausea detection in relation to the noise ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03593811

Noninvasive Markers of Functional Nausea in Children Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... Diagnostic Test : 36 channel high resolution electrogastrogram (HR-EGG). HR ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3677658/

Electrogastrography in Adults and Children - PubMed Central Cutaneous electrogastrography (EGG) is a noninvasive technique to record gastric myoelectrical activity by means of electrodes placed on the abdominal surface.