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.

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).

Study Overview

• Status: Recruiting
• Conditions: Dyspepsia
• Intervention / Treatment: Device: Alimetry; Device: tVNS; Device: Gastroduodenal Manometry

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shelly L Ward; Phone Number: 507-538-9997; Email: Ward.Shelly1@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Principal Investigator: Nicholas R Oblizajek, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study; First arm evaluating patients undergoing clinically indicated gastroduodenal manometry evaluation with concurrent body surface gastric mapping (BSGM), with taVNS applied during the studies.	Device: Alimetry; High resolution gastric mapping of electrical gastric activity.; Device: tVNS; Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.; Device: Gastroduodenal Manometry; Pressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied
Experimental: Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone; 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.	Device: Alimetry; High resolution gastric mapping of electrical gastric activity.; Device: tVNS; Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal Antral and Duodenal Contraction Frequency	Summarized as frequency (number of contractions per minute)	During gastrointestinal motility study (approx. 8 hours)
Gastrointestinal Antral and Duodenal Contraction Amplitude	Summarized as amplitude (strength of contractions)	During gastrointestinal motility study (approx. 8 hours)
Gastrointestinal Antral and Duodenal Phasic Pressure Activity - Motility Index	Composite measure combining frequency and amplitude for overall assessment of motility	During gastrointestinal motility study (approx. 8 hours)
Principal Gastric Frequency	Dominant frequency of gastric waves (cycles per minute)	During gastrointestinal motility study (8 hours)
BMI-Adjusted Amplitude	Amplitude of the gastric myoelectrical signals adjusted for body mass index	During gastrointestinal motility study (8 hours)
Gastric Alimetry Rhythm Index (TM)	Concentration of power within the gastric frequency band over time, stability of gastric rhythm	During gastrointestinal motility study (8 hours)
Fed:Fasted Amplitude Ratio	Ratio compares the amplitude of gastric myoelectrical activity in the fed state to the fasting state, reflecting gastric response to a meal	During gastrointestinal motility study (8 hours)

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Nicholas R Oblizajek, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID Numbers: 25-000214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No