High Resolution Gastric Mapping and Gastroduodenal Manometry for Indigestion

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Opioids

Disqualifiers: Cardiac arrhythmia, Major ECG abnormalities, others

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

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand and treat functional dyspepsia, a condition causing persistent stomach discomfort and indigestion. Researchers will study stomach movement and sensation, using advanced tools to track gastric activity and pressure. Participants will receive a treatment called tVNS (transcutaneous vagus nerve stimulation), a non-invasive method believed to help with these symptoms. This trial may suit those who have experienced symptoms of functional dyspepsia for at least six months. As an unphased trial, this study offers a unique opportunity to contribute to scientific understanding and potentially benefit from innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications, but it does exclude those using opioids. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that these methods are safe for assessing dyspepsia?

Research has shown that transcutaneous auricular vagus nerve stimulation (tVNS) is safe for treating functional dyspepsia. One study reported no serious side effects with tVNS treatment. It improved symptoms without causing major problems, indicating that tVNS is generally well-tolerated.

For gastroduodenal manometry, studies primarily focus on its role in diagnosing dyspepsia rather than its safety as a treatment. This procedure helps understand stomach and intestinal function and is generally considered safe when performed by experienced healthcare providers.

Overall, both tVNS and gastroduodenal manometry appear safe, with strong evidence indicating that tVNS is well-tolerated in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores high-resolution gastric mapping and gastroduodenal manometry, combined with transcutaneous vagus nerve stimulation (tVNS), to better understand indigestion. Unlike traditional treatments, which often focus on medications like proton pump inhibitors or dietary changes, this trial investigates the body's gastric and nerve activity with innovative mapping techniques. tVNS is particularly intriguing because it non-invasively stimulates the vagus nerve, potentially offering a novel approach to managing symptoms by directly targeting nerve pathways involved in digestion. By mapping gastric activity in high resolution, researchers hope to uncover precise insights into the causes of indigestion and improve treatment strategies.

What evidence suggests that this trial's treatments could be effective for dyspepsia?

Research has shown that transcutaneous auricular vagal nerve stimulation (tVNS) might help with functional dyspepsia, a type of indigestion. In this trial, some participants will undergo gastroduodenal manometry with concurrent body surface gastric mapping while receiving tVNS. Studies found that using tVNS for four weeks greatly improved symptoms in adults with this condition and helped the stomach adjust better when eating. No serious side effects were reported, indicating it is a safe option. These findings suggest tVNS could effectively manage dyspepsia symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Nicholas R Oblizajek, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals experiencing indigestion, specifically functional dyspepsia. It aims to understand stomach function disturbances and find noninvasive treatments. Participants should have symptoms of dyspepsia but the full eligibility criteria are not provided.

Inclusion Criteria

I have had stomach upset symptoms for 6 months.

I can understand and agree to the study's requirements.

Exclusion Criteria

Conditions precluding safe use of taVNS

Vulnerable study population

Pregnant women

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Gastrointestinal Motility Study

Participants undergo gastroduodenal manometry evaluation with concurrent body surface gastric mapping (BSGM) and transcutaneous auricular vagal nerve stimulation (taVNS) applied during the studies

8 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the motility study

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Alimetry
• Gastroduodenal Manometry
• tVNS

Trial Overview The study tests how tVNS (transcutaneous vagus nerve stimulation), gastroduodenal manometry (a test measuring pressure in the stomach and small intestine), and alimetry (possibly related to food intake measurement) correlate with indigestion symptoms.

How Is the Trial Designed?

Group I: Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone Experimental Treatment 2 Interventions

Participants who have been seen in the clinical setting, having undergone other clinically indicated testing, will be recruited to undergo body surface gastric mapping (BSGM). At the end of the protocolized BSGM study the patient will undergo taVNS intervention.

Group II: Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study Experimental Treatment 3 Interventions

First arm evaluating patients undergoing clinically indicated gastroduodenal manometry evaluation with concurrent body surface gastric mapping (BSGM), with taVNS applied during the studies.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. nature.com nature.com/articles/s41598-023-41645-w

Comparison of Gastric Alimetry® body surface ... Gastric Alimetry is a new diagnostic test that combines high-resolution body surface gastric mapping (BSGM) with validated symptom profiling.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10685974/

Longitudinal outcome monitoring in patients with chronic ... The Gastric Alimetry platform offers a multimodal assessment of gastric function through body surface gastric mapping (BSGM) and concurrent ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06411574

NCT06411574 | Body Surface Gastric Mapping Vs ... Previous research revealed that the detection of gastric motility abnormality rates through patient phenotyping were higher using Gastric Alimetry compared to ...

4. mdpi.com mdpi.com/2077-0383/12/20/6436

Gastric Alimetry® Test Interpretation in Gastroduodenal ... This paper presents a systematic methodology for Gastric Alimetry test interpretation, together with an extensive supporting literature review.

5. medrxiv.org medrxiv.org/content/10.1101/2024.05.13.24307307v1

BODY SURFACE GASTRIC MAPPING DELINEATES ... Objective This study aimed to assess the utility of BSGM in delineating specific patient phenotypes among adolescents with functional dyspepsia ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8132673/

Functional Dyspepsia: A Review of the Symptoms ... Up to 70% of patients with functional dyspepsia have abnormal antroduodenal manometry results, and approximately 40% have impaired gastric accommodation.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0344033825004133

New Frontiers in Functional Dyspepsia and Gastroparesis We discuss evolving diagnostic techniques, including gastric emptying scintigraphy and novel approaches like wireless motility capsules.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9955554/

Diagnostic Methods for Evaluation of Gastric Motility—A Mini ... In this study, the satiation drinking test was predictive of impairment in gastric accommodation with sensitivity and specificity of 92% and 86% ...

9. journals.physiology.org journals.physiology.org/doi/pdf/10.1152/ajpgi.00101.2023

Physiological characterization of gastric emptying using ... Using HR-ADM, patients with delayed GE displayed different postprandial antropyloric motility as compared with patients with normal GE. NEW & ...

10. medrxiv.org medrxiv.org/content/10.1101/2024.11.14.24317342v1.full-text

a Comparison with Antroduodenal Manometry Neuropathic Gastroduodenal Disorders can be Diagnosed by Non-Invasive Body Surface Gastric Mapping: a Comparison with Antroduodenal Manometry.