High Resolution Gastric Mapping and Gastroduodenal Manometry

Mayo Clinic

Status: Enrolling

Conditions: Dyspepsia

Treatments: Device: Gastroduodenal Manometry; Device: tVNS; Device: Alimetry

Study type: Interventional

Funder types: Other

Identifiers

NCT06941545

25-000214

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Dyspeptic Patients undergoing clinically indicated gastroduodenal manometry study

Experimental group

Description:

First arm evaluating patients undergoing clinically indicated gastroduodenal manometry evaluation with concurrent body surface gastric mapping (BSGM), with taVNS applied during the studies.

Treatment:

Device: Alimetry

Device: tVNS

Device: Gastroduodenal Manometry

Dyspeptic patients not undergoing GDM, tested with body surface gastric mapping alone

Experimental group

Description:

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.

Treatment:

Device: Alimetry

Device: tVNS