Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06941545

High Resolution Gastric Mapping and Gastroduodenal Manometry

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Dyspepsia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Nicholas R Oblizajek, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alimetry

Device

High resolution gastric mapping of electrical gastric activity.

tVNS

Device

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

Gastroduodenal Manometry

Device

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

Primary outcomes

  1. Gastrointestinal Antral and Duodenal Contraction Frequency

    Time frame: During gastrointestinal motility study (approx. 8 hours)

    Summarized as frequency (number of contractions per minute)

  2. Gastrointestinal Antral and Duodenal Contraction Amplitude

    Time frame: During gastrointestinal motility study (approx. 8 hours)

    Summarized as amplitude (strength of contractions)

  3. Gastrointestinal Antral and Duodenal Phasic Pressure Activity - Motility Index

    Time frame: During gastrointestinal motility study (approx. 8 hours)

    Composite measure combining frequency and amplitude for overall assessment of motility

  4. Principal Gastric Frequency

    Time frame: During gastrointestinal motility study (8 hours)

    Dominant frequency of gastric waves (cycles per minute)

  5. BMI-Adjusted Amplitude

    Time frame: During gastrointestinal motility study (8 hours)

    Amplitude of the gastric myoelectrical signals adjusted for body mass index

  6. Gastric Alimetry Rhythm Index (TM)

    Time frame: During gastrointestinal motility study (8 hours)

    Concentration of power within the gastric frequency band over time, stability of gastric rhythm

  7. Fed:Fasted Amplitude Ratio

    Time frame: During gastrointestinal motility study (8 hours)

    Ratio compares the amplitude of gastric myoelectrical activity in the fed state to the fasting state, reflecting gastric response to a meal

Study contacts

Contact information is provided by the study sponsor or research team.

Shelly L Ward

CONTACT

[email protected]

507-538-9997

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.