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RECRUITING
NCT07632378
NA

The Effect of taVNS and Upper GI Motility

Sponsor: Daniel Keszthelyi

View on ClinicalTrials.gov

Summary

This single-center randomized controlled cross-over trial aims to investigate the effect of transcutaneous auricular vagus nerve stimulation on upper gastrointestinal motility in healthy individuals. The primary aim of this study is to assess the impact of tVNS on gut motor function, with regards to its potential to induce phase III contractions in the upper GI tract. Secondary objectives include: * To study the effect of tVNS on other parameters characterizing upper GI motility such as the number of duodenal phase III contractions, gastric and duodenal phase MMCs, amplitude of antral contractions and motility index * To study the effect of tVNS on plasma levels of motilin and PP * To evaluate the effect of tVNS on parameters related to autonomic outflow, using a Shimmer3 GSR Sensor for heart rate variability and skin conductance. * To compare the results of the measurements of antroduodenal manometry with measurements of Gastric Alimetry Participants will undergo tVNS (applied to the cymba conchae of the left ear) alternating with sham stimulation (using a non-conducting electrode) in a blinded, pre-randomized fashion, using two 4-hour blocks during an 8-hour fasted antroduodenal manometry recording period. Optionally, participants may simultaneously also undergo body surface gastric mapping using the Gastric Alimetry system.

Official title: The Effect of Non-invasive Transauricular Vagus Nerve Stimulation on Upper Gastrointestinal Motility in Healthy Individuals

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-02-25

Completion Date

2026-06

Last Updated

2026-06-08

Healthy Volunteers

Yes

Interventions

DEVICE

Vagal Nerve Stimulation

taVNS will be provided during a 4-hour block of the 8-hour fasted antroduodenal manometry recording period.

DEVICE

Sham stimulation

Sham stimulation will be provided during a 4-hour block of the 8-hour fasted antroduodenal manometry recording period.

Locations (1)

Maastricht University

Maastricht, Limburg, Netherlands