Caudal ear nerve stimulation to test gut movement in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, randomized crossover trial evaluates the effects of transcutaneous auricular vagus nerve stimulation (tVNS) on upper gastrointestinal motility in healthy adults. Participants undergo 8 hours of upper GI motility recording with manometry while receiving either active tVNS or sham stimulation in random order. Secondary measures include duodenal phase III contractions, gastric and duodenal MMCs, antral contraction amplitude, motility index, motilin and peptide YY levels, autonomic markers, and comparison with Gastric Alimetry data. The study uses standard safety procedures, screening, and imaging guidance for catheter placement, with data managed in Castor EDC at Maastricht University Medical Center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Pregnancy or lactation.
* Use of any substances (such as medication or recreational drugs) influencing gastrointestinal motility
* Not meeting the inclusion criteria above.
* 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.

Where it's running

• Maastricht University
  Maastricht, Limburg, Netherlands Recruiting

Study contacts

• Principal investigator: Daniel Keszthelyi, MD, PhD — Maastricht University Medical Center
• Study coordinator: Kimberly Hawinkels, MD
• Email: kimberly.hawinkels@maastrichtuniversity.nl
• Phone: +31883887808

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.