The Effect of taVNS and Upper GI Motility
ConditionHealthy Adult Participants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorDaniel Keszthelyi
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Vagal Nerve Stimulation
DevicetaVNS will be provided during a 4-hour block of the 8-hour fasted antroduodenal manometry recording period.
Sham stimulation
DeviceSham stimulation will be provided during a 4-hour block of the 8-hour fasted antroduodenal manometry recording period.
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: Transcutaneous Auricular Vagal Nerve StimulationActive comparator 1 intervention
Group B: Sham stimulationPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)Secondary outcomes
1
A clinically relevant increase in other upper GI motility parameters
A clinically relevant increase in 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
Time frame
Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)2
Concentration of plasma motilin and pancreatic polypeptide
Changes in plasma motilin and pancreatic polypeptide following taVNS vs. sham stimulation
Time frame
Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)3
Autonomic response: heart rate variability
Changes in heart rate variability measured continuously using a Shimmer3 GSR sensor
Time frame
Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)4
Electrodermal response: skin conductance
Changes in skin conductance following taVNS vs sham stimulation, assessed continuously using a Shimmer3 GSR sensor.
Time frame
Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Daniel Keszthelyi
Lead sponsor
Academisch Ziekenhuis Maastricht
Sponsor institution
Source ClinicalTrials.gov