High Resolution Gastric Mapping and Gastroduodenal Manometry

NCT06941545 | Recruiting FDA Device

• 1 other identifier: 25-000214
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (7)

• 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)

Study Arms (2)

Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study

EXPERIMENTAL

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; Device: tVNS; Device: Gastroduodenal Manometry

Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone

EXPERIMENTAL

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; Device: tVNS

Interventions

Alimetry DEVICE

High resolution gastric mapping of electrical gastric activity.

Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study; Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone

tVNS DEVICE

Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.

Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study; Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone

Gastroduodenal Manometry DEVICE

Pressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied

Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms consistent with functional dyspepsia as defined by the ROME IV criteria for 6 months
• Ability to perform appropriate informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Dyspepsia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicholas R Oblizajek, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelly L Ward

CONTACT

507-538-9997; Ward.Shelly1@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 23, 2025
• Study Start: July 11, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)