Actively Recruiting
Assessment of Gastrointestinal Function Using High Resolution Gastric Mapping, Gastroduodenal Manometry, Gastric Emptying Testing, and Response to Transcutaneous Auricular Vagal Nerve Stimulation
Led by Mayo Clinic · Updated on 2025-08-19
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Dyspepsia is a common digestive problem linked to abnormal stomach movements such as delayed or rapid gastric emptying, impaired stomach relaxation, and increased stomach sensitivity. Researchers aim to better understand these dysfunctions by identifying specific patterns and symptoms in patients with functional dyspepsia, and by exploring how symptoms relate to stomach emptying, electrical activity, and pressure changes. This study is conducted by Mayo Clinic to improve objective knowledge and find safe, noninvasive treatment options for dyspepsia. Participants will undergo evaluations using devices that measure electrical activity of the stomach (body surface gastric mapping, BSGM) and pressure inside the stomach and duodenum (gastroduodenal manometry). Some participants will receive transcutaneous auricular vagal nerve stimulation (taVNS), a form of electrical stimulation applied to the ear, during these assessments. One group will have both manometry and BSGM with taVNS applied during the study, while another group will undergo only BSGM followed by taVNS intervention. During the approximately 8-hour motility studies, researchers will monitor stomach and duodenal contraction frequency, amplitude, pressure activity, and electrical rhythm using the devices. Participants will be observed for correlations between symptoms experienced during testing and daily life. The study includes careful monitoring of physiological responses and symptom assessments to characterize gastric function and the effects of taVNS. Total participation time varies per individual, with no masking or randomization involved.
CONDITIONS
Brief Title
High Resolution Gastric Mapping and Gastroduodenal Manometry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Symptoms consistent with functional dyspepsia as defined by the ROME IV criteria for at least 6 months
- Ability to provide informed consent
You will not qualify if you...
- Known cardiac arrhythmia or major ECG abnormalities such as 2nd or 3rd degree AV block, prolonged QTc interval above 460 msec, or bradycardia below 45 beats per minute
- Conditions that prevent safe use of transcutaneous auricular vagal nerve stimulation (taVNS)
- Significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease interfering with study objectives or safety
- Use of opioid medications
- Vulnerable populations
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 8 hours on the study day
Participants undergo high resolution gastric mapping and gastroduodenal manometry studies. Transcutaneous auricular vagal nerve stimulation (taVNS) is applied during these assessments.
1 study visit (in-person)
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
S
Shelly L Ward
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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