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The Effect of taVNS and Upper GI Motility

RecruitingNAAges 18 Years - 55 YearsAllDaniel Keszthelyi
NCT07632378 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 antrod

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📋 Eligibility rules (as published)
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.
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What it tests

  • Vagal Nerve Stimulation
  • Sham stimulation
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Where

1 site
Maastricht University
Maastricht, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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