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The Effect of taVNS and Upper GI Motility

NCT07632378 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-06-08

No results posted yet for this study

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.

Conditions

  • Healthy Adult Participants

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.

Sponsors & Collaborators

  • Daniel Keszthelyi

    lead OTHER

Principal Investigators

  • Daniel Keszthelyi, MD, PhD · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-25
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07632378 on ClinicalTrials.gov