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

50 Participants Needed

Trial Summary

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.

How is the treatment tVNS for indigestion different from other treatments?

tVNS (transcutaneous vagus nerve stimulation) is unique because it uses electrical impulses to stimulate the vagus nerve through the skin, which is different from traditional medications that are taken orally or intravenously. This non-invasive approach may offer a novel way to manage indigestion by potentially improving gastric function without the need for drugs. ^{1 2 3 4 5}

What is the purpose of this trial?

Dyspepsia is a common problem attributed to gastric sensorimotor dysfunctions ie, delayed, or less frequently rapid gastric emptying (GE), impaired gastric accommodation, and increased gastric sensation. Therapeutic options manage symptoms, and there is no FDA approved medical therapy for dyspepsia. There is a need for better objective understanding of sensorimotor dysfunction in dyspepsia, as well as noninvasive, efficacious, safe, and inexpensive treatments for dyspepsia. The purpose of this research is to identify disturbances and characterize phenotypes in patients with functional dyspepsia, and to assess the correlations between symptoms (during the manometry and in daily life), gastric emptying, electrical activity (BSGM), and pressure activity (manometry).

Research Team

Nicholas R Oblizajek, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Dyspeptic Patients Experimental Treatment 3 Interventions

Single arm evaluating patients undergoing 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+

References

1. England pubmed.ncbi.nlm.nih.gov

A novel scalable electrode array and system for non-invasively assessing gastric function using flexible electronics. [2023]

2. China pubmed.ncbi.nlm.nih.gov

Temporal and spatial relationship of pylorus to antroduodenal motility in functional dyspepsia. [2004]

3. Ireland pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in the evaluation of the gastric emptying and antral motion: feasibility and reproducibility of a fast not invasive technique. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Dynamic antral scintigraphy to characterize gastric antral motility in functional dyspepsia. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The pH/PCO2 method for continuous determination of human gastric acid and bicarbonate secretion. A validation study. [2019]