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NCT06941545NARecruiting

High Resolution Gastric Mapping and Gastroduodenal Manometry

Mayo Clinic

Start Date

7/11/2025

Completion Date

12/31/2026

Summary

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).

Eligibility Criteria

Age Range: 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

Interventions

DEVICE

Alimetry

DEVICE

tVNS

DEVICE

Gastroduodenal Manometry

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Conditions

Dyspepsia

Locations

Mayo Clinic in Rochester

Rochester, Minnesota 55905

United States