An interventional study of Alimetry and tVNS in Dyspepsia, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Health services research
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).
372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.
This study's planned enrollment of 100 is above the median of 89 across 302 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
High resolution gastric mapping of electrical gastric activity.
Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.
Pressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied
Gastrointestinal Antral and Duodenal Contraction Frequency
Summarized as frequency (number of contractions per minute)
Time frame: During gastrointestinal motility study (approx. 8 hours)
Gastrointestinal Antral and Duodenal Contraction Amplitude
Summarized as amplitude (strength of contractions)
Time frame: 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
Time frame: During gastrointestinal motility study (approx. 8 hours)
Principal Gastric Frequency
Dominant frequency of gastric waves (cycles per minute)
Time frame: During gastrointestinal motility study (8 hours)
BMI-Adjusted Amplitude
Amplitude of the gastric myoelectrical signals adjusted for body mass index
Time frame: 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
Time frame: 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
Time frame: During gastrointestinal motility study (8 hours)
Plan to share: No
Started Jul 2025 (actual). Primary completion is estimated for Dec 2026, 17 months after the start.
Of 71 non-industry interventional studies with no phase under Dyspepsia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 28. This study's planned 17 months is close to that.
Counting every sponsor, half of 79 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
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