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Understanding Dyspepsia with Gastric Mapping and Manometry

This study aims to better understand functional dyspepsia, a common stomach problem, by looking at how your stomach and small intestine move and function. Researchers will use three devices: Alimetry (for high-resolution gastric mapping of electrical activity), tVNS (Transcutaneous Auricular Vagal Nerve Stimulation, which uses electrical stimulation to the ear), and Gastroduodenal Manometry (a pressure catheter to measure stomach and small intestine pressure). The goal is to identify different patterns of dysfunction in dyspepsia and see how these relate to your symptoms. You may be able to join if you are 18 to 80 years old and have had symptoms of functional dyspepsia for at least six months. The study will measure the frequency and strength of contractions in your stomach and small intestine. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 100 participants. The study aims to identify disturbances and characterize phenotypes in patients with functional dyspepsia.
What's involved
During the gastrointestinal motility study, which lasts approximately 8 hours, you will undergo measurements of your stomach and small intestine activity.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured during the gastrointestinal motility study (approximately 8 hours).

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NCT06941545

High Resolution Gastric Mapping and Gastroduodenal Manometry

Recruiting
NAAges 18–80InterventionalHealth services
Mayo Clinic
~100 participants
Updated 2025-08-19 on ClinicalTrials.gov
What's tested:AlimetrytVNSGastroduodenal Manometry

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Gastrointestinal Antral and Duodenal Contraction Frequency
Measured over During gastrointestinal motility study (approx. 8 hours)
+6 more outcomes measured

Conditions

Dyspepsia

Explore related trials

Dyspepsia

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Nicholas R Oblizajek, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Shelly L Ward
[email protected]
507-538-9997
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Gastrointestinal Antral and Duodenal Contraction FrequencyDuring gastrointestinal motility study (approx. 8 hours)

    Summarized as frequency (number of contractions per minute)

  • Gastrointestinal Antral and Duodenal Contraction AmplitudeDuring gastrointestinal motility study (approx. 8 hours)

    Summarized as amplitude (strength of contractions)

  • Gastrointestinal Antral and Duodenal Phasic Pressure Activity - Motility IndexDuring gastrointestinal motility study (approx. 8 hours)

    Composite measure combining frequency and amplitude for overall assessment of motility

  • Principal Gastric FrequencyDuring gastrointestinal motility study (8 hours)

    Dominant frequency of gastric waves (cycles per minute)

  • BMI-Adjusted AmplitudeDuring gastrointestinal motility study (8 hours)

    Amplitude of the gastric myoelectrical signals adjusted for body mass index

  • Gastric Alimetry Rhythm Index (TM)During gastrointestinal motility study (8 hours)

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

  • Fed:Fasted Amplitude RatioDuring 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