The Effect of taVNS and Upper GI Motility

NCT07632378 | Recruiting

• 1 other identifier: NL86446.068.24
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vagal Nerve Stimulation; Upper GI motility; Randomised Controlled Trial; Antroduodenal Manometry; Gastric Alimetry

Outcome Measures

Primary Outcomes (1)

• A clinically meaningful increase in phase III contractions

  A clinically meaningful increase in the number of phase III contractions of antral origin in the fasted period during the tVNS stimulation compared to the sham stimulation.

  Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)

Secondary Outcomes (5)

• A clinically relevant increase in other upper GI motility parameters

  Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)

• Concentration of plasma motilin and pancreatic polypeptide

  Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)

• Autonomic response: heart rate variability

  Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)

• Electrodermal response: skin conductance

  Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)

• Agreement between gastric motility measurements obtained by antroduodenal manometry and Gastric Alimetry

  Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)

Study Arms (2)

Transcutaneous Auricular Vagal Nerve Stimulation

ACTIVE COMPARATOR

TaVNS

Device: Vagal Nerve Stimulation

Sham stimulation

PLACEBO COMPARATOR

Sham stimulation with a non-conducting electrode

Device: Sham stimulation

Interventions

Vagal Nerve Stimulation DEVICE

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

Transcutaneous Auricular Vagal Nerve Stimulation

Sham stimulation DEVICE

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

Sham stimulation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants (defined as those without a pre-existing medical comorbidity, including those without a history of cardiac arrhythmia).
• Age between 18 and 55 years.
• Ability to understand and speak the Dutch language.

You may not qualify if:

• Pregnancy or lactation.
• Use of any substances (such as medication or recreational drugs) influencing gastrointestinal motility
• Students and employees of Maastricht University are not precluded from participation, unless they have a direct personal, professional of hierarchical position with regards to any of the study team members or their department.

Sponsors & Collaborators

• Daniel Keszthelyi: lead

Study Sites (1)

Maastricht University

Maastricht, Limburg, 6229ER, Netherlands

RECRUITING

MeSH Terms

Interventions

Vagus Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Daniel Keszthelyi, MD, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Hawinkels, MD

CONTACT

+31883887808; kimberly.hawinkels@maastrichtuniversity.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Keszthelyi

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 8, 2026
• Study Start: February 25, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)