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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study | Experimental | First arm evaluating patients undergoing clinically indicated gastroduodenal manometry evaluation with concurrent body surface gastric mapping (BSGM), with taVNS applied during the studies. |
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| Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alimetry | Device | High resolution gastric mapping of electrical gastric activity. |
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| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Antral and Duodenal Contraction Frequency | Summarized as frequency (number of contractions per minute) | During gastrointestinal motility study (approx. 8 hours) |
| Gastrointestinal Antral and Duodenal Contraction Amplitude | Summarized as amplitude (strength of contractions) | 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 | During gastrointestinal motility study (approx. 8 hours) |
| Principal Gastric Frequency | Dominant frequency of gastric waves (cycles per minute) | During gastrointestinal motility study (8 hours) |
| BMI-Adjusted Amplitude | Amplitude of the gastric myoelectrical signals adjusted for body mass index | 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 | 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shelly L Ward | Contact | 507-538-9997 | Ward.Shelly1@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nicholas R Oblizajek, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| tVNS | Device | Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear. |
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| Gastroduodenal Manometry | Device | Pressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied |
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| During gastrointestinal motility study (8 hours) |