Dyspepsia
Conditions
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).
Interventions
DEVICEAlimetry
High resolution gastric mapping of electrical gastric activity.
DEVICEtVNS
Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.
DEVICEGastroduodenal Manometry
Pressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI-Adjusted Amplitude | During gastrointestinal motility study (8 hours) | Amplitude of the gastric myoelectrical signals adjusted for body mass index |
| Gastrointestinal Antral and Duodenal Contraction Frequency | During gastrointestinal motility study (approx. 8 hours) | Summarized as frequency (number of contractions per minute) |
| Gastrointestinal Antral and Duodenal Contraction Amplitude | During gastrointestinal motility study (approx. 8 hours) | Summarized as amplitude (strength of contractions) |
| Gastrointestinal Antral and Duodenal Phasic Pressure Activity - Motility Index | During gastrointestinal motility study (approx. 8 hours) | Composite measure combining frequency and amplitude for overall assessment of motility |
| Principal Gastric Frequency | During gastrointestinal motility study (8 hours) | Dominant frequency of gastric waves (cycles per minute) |
| Gastric Alimetry Rhythm Index (TM) | During gastrointestinal motility study (8 hours) | Concentration of power within the gastric frequency band over time, stability of gastric rhythm |
| Fed:Fasted Amplitude Ratio | During gastrointestinal motility study (8 hours) | Ratio compares the amplitude of gastric myoelectrical activity in the fed state to the fasting state, reflecting gastric response to a meal |
Countries
United States
Contacts
Primary ContactShelly L Ward
Outcome results
None listed