Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT06941545

Conditions

Dyspepsia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Alimetry

tVNS

Gastroduodenal Manometry

Study Details

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

Study ID

NCT06941545

Start date

Jul 11, 2025

Status verified date

Aug, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Alimetry

High resolution gastric mapping of electrical gastric activity.

tVNS

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

Gastroduodenal Manometry

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

Primary outcome measure

  • Gastrointestinal Antral and Duodenal Contraction Frequency [ Time Frame: During gastrointestinal motility study (approx. 8 hours) ]
  • Gastrointestinal Antral and Duodenal Contraction Amplitude [ Time Frame: During gastrointestinal motility study (approx. 8 hours) ]
  • Gastrointestinal Antral and Duodenal Phasic Pressure Activity - Motility Index [ Time Frame: During gastrointestinal motility study (approx. 8 hours) ]
  • Principal Gastric Frequency [ Time Frame: During gastrointestinal motility study (8 hours) ]
  • BMI-Adjusted Amplitude [ Time Frame: During gastrointestinal motility study (8 hours) ]
  • Gastric Alimetry Rhythm Index (TM) [ Time Frame: During gastrointestinal motility study (8 hours) ]
  • Fed:Fasted Amplitude Ratio [ Time Frame: During gastrointestinal motility study (8 hours) ]

Central Contacts and Locations

Central contacts

Shelly L Ward

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

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Principal Investigator:

Nicholas R Oblizajek, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 19, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-08-19.