NCT06700200

TVNS and Upper GI Motility

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To study the impact of tVNS on gut motor function, with regards to its potential to induce phase III contractions in the upper GI tract, in healthy subjects. Hypothesis: We hypothesize that tVNS will induce on average an excess of 1 additional phase III contraction of antral origin in the fasted period compared to sham stimulation.

Detailed description

Healthy volunteers (n=12) will be recruited, both male and female, aged aged 18-55 years old. Participants will arrive after an overnight fast at the GI physiology unit ('functiekamer') of the Maastricht University Medical Center, where they will be inserted an antroduodenal manometry catheter through the nose into the duodenum under fluoroscopy control. The high-resolution catheter contains 36 transducers spaced at 1-cm intervals (Unisensor AG, Attikon, Switzerland). Using this catheter, stomach and duodenum motility patterns will be recorded for 8 hours. Participants will undergo tVNS (cymba concha of the left ear) alternated with sham (a non-conducting electrode) in a blinded pre-randomized fashion using 2 blocks of 4 hours during the 8-hour registration period. In addition, blood samples will be taken at baseline and at intervals of 30 minutes during the 8-hour test period. Levels of the GI hormones motilin and PP will be measured as surrogate markers of vagal efferent influence on GI motor function. Autonomic parameters will be registered using pulse plethysmography. A wearable device (Shimmer3 GSR Sensor) will also be used to measure heart rate variability and skin conductance. Heart rate variability is regarded as a parameter reflecting cardiac parasympathetic activity.(33, 34) The root mean square of successive differences (RMSSD) is a commonly utilized and thoroughly validated measure of heart (and pulse) rate variability. (35, 36). After the 8-hour registration period, all measurement equipment and the iv. cannula is removed. Participants are provided a meal voucher to be consumed at the hospital visitor's restaurant, whereafter the test day is finished.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DEVICE	taVNS	transauricular vagus nerve stimulation

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-11-21
• Last updated: 2024-11-21