High Resolution Gastric Mapping and Gastroduodenal Manometry

Mayo Clinic100 enrolled

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

100

Conditions

Dyspepsia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

High Resolution Gastric Mapping and Gastroduodenal Manometry

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts