taVNS
Devicetransauricular vagus nerve stimulation
NCT Number: NCT06700200
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.
Trial opening soon.
Get Notified18 year–55 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
transauricular vagus nerve stimulation
Time frame: During ADM
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.
Time frame: During ADM
Blood samples will be taken every 30 minutes
Time frame: During ADM
Contact information is provided by the study sponsor or research team.
Maastricht University Medical Center
Other
The Effect of Non-invasive Transauricular Vagus Nerve Stimulation on Upper Gastrointestinal Motility in Healthy Individuals
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