High Resolution Gastric Mapping and Gastroduodenal Manometry
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.
Mayo Clinic
100 participants
Jul 11, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- Symptoms consistent with functional dyspepsia as defined by the ROME IV criteria for 6 months
- Ability to perform appropriate informed consent
Exclusion Criteria6
- 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
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Interventions
High resolution gastric mapping of electrical gastric activity.
Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.
Pressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied
Locations(1)
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NCT06941545