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.
| Registry | NCT06941545 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, parallel, masking: none, health services research |
| Enrollment | 100 (Estimated) |
| Sponsor | Mayo Clinic (Other) |
| Conditions | Dyspepsia |
| Interventions | Alimetry, tVNS, Gastroduodenal Manometry (Device) |
| Dates | start 2025-07-11, primary completion 2026-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2025-04-23, last updated 2026-09-11 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Dyspepsia All trials of Alimetry All trials of tVNS
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study | Experimental | Device: Alimetry; Device: tVNS; Device: Gastroduodenal Manometry | First arm evaluating patients undergoing clinically indicated gastroduodenal manometry evaluation with concurrent body surface gastric mapping (BSGM), with taVNS applied during the studies. |
| Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone | Experimental | Device: Alimetry; Device: tVNS | 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. |
Sex: All, ages: 18 Years to 80 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Mayo Clinic in Rochester | Rochester, Minnesota | United States | Recruiting |