High Resolution Gastric Mapping and Gastroduodenal Manometry

Purpose

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).

Condition

  • Dyspepsia

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study 		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
    High resolution gastric mapping of electrical gastric activity.
  • Device: tVNS
    Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.
  • Device: Gastroduodenal Manometry
    Pressure catheter evaluating gastric and duodenal pressure profiles at rest and with certain stimuli applied
Experimental
Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone 		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
    High resolution gastric mapping of electrical gastric activity.
  • Device: tVNS
    Transcutaneous Auricular Vagal Nerve Stimulation, electrical stimulation to the ear.

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Shelly L Ward
507-538-9997
Ward.Shelly1@mayo.edu