High-resolution stomach mapping with gastroduodenal pressure testing
Official title: An Assessment of Gastrointestinal Function Utilizing High Resolution Gastric Mapping, Gastroduodenal Manometry, and Gastric Emptying Testing With Assessment of Acute Response to Transcutaneous Auricular Vagal Nerve Stimulation.
Run by Mayo Clinic · NCT06941545 · Data updated 2026-11-12
This study tests whether high-resolution body-surface gastric mapping and gastroduodenal manometry, with or without transcutaneous vagal nerve stimulation (tVNS), can identify stomach dysfunction patterns that match symptoms in people with functional dyspepsia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Status | Recruiting |
| Started | July 11, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 11, 2026 |
| Trial ID | NCT06941545 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with symptoms meeting Rome IV criteria for functional dyspepsia for at least six months who can consent and who do not have contraindications to tVNS or manometry are ideal candidates.
✕Probably not a fit
Patients with structural gastrointestinal disease, major unstable medical comorbidities, significant cardiac conduction abnormalities, current opioid use, pregnancy, or other contraindications to tVNS or manometry may not receive benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with functional dyspepsia (Rome IV, ≥6 months) undergo noninvasive high-resolution body-surface gastric mapping (Alimetry) and invasive gastroduodenal manometry to record electrical and pressure activity. Gastric emptying data and standardized symptom recordings during testing and in daily life are collected. A subset receives transcutaneous vagal nerve stimulation (tVNS) to explore acute effects on electrophysiology, pressure patterns, and symptoms. Investigators will correlate symptom profiles with gastric electrical activity, pressure measurements, and gastric emptying to define objective phenotypes.
Why it matters
Potential benefit: If successful, this approach could identify objective dyspepsia subtypes and support targeted, noninvasive treatments such as tVNS to reduce symptoms.
How similar studies have gone: Early pilot studies using body-surface gastric mapping and small trials of tVNS have shown promising signals for symptom and physiological changes, but larger confirmatory studies are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria * Symptoms consistent with functional dyspepsia as defined by the ROME IV criteria for 6 months * Ability to perform appropriate informed consent Exclusion Criteria * Known cardiac arrhythmia or major ECG abnormalities, i.e. cardiac conduction disturbances (2nd or 3rd degree AV block, prolonged QTc interval (\> 460 msec) or bradycardia (\< 45 beats/minute) * Conditions precluding safe use of taVNS * Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns * Use of opioids * Vulnerable study population * Pregnant women
Where it's running
-
Mayo Clinic in Rochester
Rochester, Minnesota, United States Recruiting
Study contacts
- Principal investigator: Nicholas R Oblizajek, MD — Mayo Clinic
- Study coordinator: Shelly L Ward
- Email: Ward.Shelly1@mayo.edu
- Phone: 507-538-9997
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.