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Recruiting NCT06941545

High Resolution Gastric Mapping and Gastroduodenal Manometry

No phase Interventional Dyspepsia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Alimetry, tVNS, Gastroduodenal Manometry.
Who it may be relevant to
Registry conditions: Dyspepsia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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).

Interventions

  • 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

Primary outcome measures

  • 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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06941545 · 25-000214

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗