Healthy Adult ParticipantsNCT07632378
The Effect of taVNS and Upper GI Motility
A study testing Vagal Nerve Stimulation in people with Healthy Adult Participants, run by Daniel Keszthelyi at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- Vagal Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 25 Feb 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University
Maastricht, Limburg, 6229ER
About this study
Official title: The Effect of Non-invasive Transauricular Vagus Nerve Stimulation on Upper Gastrointestinal Motility in Healthy Individuals
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.
Read more
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.
Read the detailed description
Visit 1 (screening visit) Following written informed consent, the medical history of each subject will be checked during a structured interview. A pregnancy will be excluded by a urine test (due to the use or fluoroscopy during insertion of the manometry catheter) and a 12-lead ECG will be performed at the end of the screening visit. The rationale for this is to ensure no evidence of cardiac conduction disorders and an additional safety step to ensure no cardiac dysrhythmic affect with tVNS use. All information obtained during the screening visit will be recorded in using an electronic CRF provided by Castor EDC, provided by the Clinical Trial Centre Maastricht (CTCM).
Visit 2 (test day) Participants will arrive after an overnight fast at the GI physiology unit of the Maastricht University Medical Center, where a trained and experienced nurse will insert an antroduodenal manometry catheter through the nose into the duodenum under fluoroscopy control and supervision of a gastroenterologist (as per routine clinical procedure). Using this catheter, stomach and duodenum motility patterns will be recorded for 8 hours. After the manometry is inserted, the tVNS device will be connected with an electrode which delivers stimulation transcutaneous in the outer ear. Participants will receive two types of stimulation (i.e. tVNS vs sham) in 2 blocks of 4 hours during the 8-hour registration period. The order of stimulation applied is randomized. Gastric phase III contractions generally occur every 90 minutes, so the 4-hour period is considered sufficient to detect two phase III contractions considered sufficient to detect the two phase III contractions.(10)
An iv catheter will be inserted to draw blood during the 8-hour registration period. Blood samples, each witch a maximum volume of 10 mL, will be taken every 30 minutes to measure motilin and PP as surrogate markers of vagal efferent influence on GI motor function. In addition, autonomic parameters will be registered during the entire test period, using a Shimmer3 GSR sensor. After the 8-hour test period, the manometry catheter, the electrodes of the tVNS device and the iv cannula are removed.
Additionally, participants may opt to take part in a body surface gastric mapping assessment. This non-invasive, electrophysiological measurement is performed using the Gastric Alimetry system, which involves placing a large adhesive patch with multiple electrodes on the upper abdomen. The system records gastric myoelectrical activity over time, providing insight into gastric motility patterns. The measurement is conducted concurrently with the manometry registration period.
- Conditions
- Healthy Adult Participants
- Being tested
- Vagal Nerve Stimulation, Sham stimulation
- Keywords
- Vagal Nerve Stimulation, Upper GI motility, Randomised Controlled Trial, Antroduodenal Manometry, Gastric Alimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagal Nerve StimulationDevice
taVNS will be provided during a 4-hour block of the 8-hour fasted antroduodenal manometry recording period.
Sham stimulationDevice
Sham stimulation will be provided during a 4-hour block of the 8-hour fasted antroduodenal manometry recording period.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Auricular Vagal Nerve Stimulation | Active comparator | TaVNS Receives: Device: Vagal Nerve Stimulation |
| Sham stimulation | Placebo comparator | Sham stimulation with a non-conducting electrode Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)
Secondary outcomes (5)
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
Measured: Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)
Concentration of plasma motilin and pancreatic polypeptide
Changes in plasma motilin and pancreatic polypeptide following taVNS vs. sham stimulation
Measured: Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)
Autonomic response: heart rate variability
Changes in heart rate variability measured continuously using a Shimmer3 GSR sensor
Measured: Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)
Electrodermal response: skin conductance
Changes in skin conductance following taVNS vs sham stimulation, assessed continuously using a Shimmer3 GSR sensor.
Measured: Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)
Agreement between gastric motility measurements obtained by antroduodenal manometry and Gastric Alimetry
Agreement between antroduodenal manometry and Gastric Alimetry measurements obtained simultaneously.
Measured: Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start25 Feb 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daniel Keszthelyi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Keszthelyi, Academisch Ziekenhuis Maastricht
- Investigators
- Daniel Keszthelyi, MD, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632378
- Sponsor's protocol ID
- NL86446.068.24
- Status last verified
- Jun 2026
- First submitted
- 26 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Non-invasive Transauricular Vagus Nerve Stimulation on Upper Gastrointestinal Motility in Healthy Individuals
- ClinicalTrials.gov ID
- NCT07632378
- Acronym / sponsor ID
- NL86446.068.24
- Conditions
- Healthy Adult Participants
- Keywords
- Vagal Nerve Stimulation, Upper GI motility, Randomised Controlled Trial, Antroduodenal Manometry, Gastric Alimetry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Daniel KeszthelyiUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Visit 1 (screening visit) Following written informed consent, the medical history of each subject will be checked during a structured interview. A pregnancy will be excluded by a urine test (due to the use or fluoroscopy during insertion of the manometry catheter) and a 12-lead ECG will be performed at the end of the screening visit. The rationale for this is to ensure no evidence of cardiac conduction disorders and an additional safety step to ensure no cardiac dysrhythmic affect with tVNS use. All information obtained during the screening visit will be recorded in using an electronic CRF provided by Castor EDC, provided by the Clinical Trial Centre Maastricht (CTCM).
Visit 2 (test day) Participants will arrive after an overnight fast at the GI physiology unit of the Maastricht University Medical Center, where a trained and experienced nurse will insert an antroduodenal manometry catheter through the nose into the duodenum under fluoroscopy control and supervision of a gastroenterologist (as per routine clinical procedure). Using this catheter, stomach and duodenum motility patterns will be recorded for 8 hours. After the manometry is inserted, the tVNS device will be connected with an electrode which delivers stimulation transcutaneous in the outer ear. Participants will receive two types of stimulation (i.e. tVNS vs sham) in 2 blocks of 4 hours during the 8-hour registration period. The order of stimulation applied is randomized. Gastric phase III contractions generally occur every 90 minutes, so the 4-hour period is considered sufficient to detect two phase III contractions considered sufficient to detect the two phase III contractions.(10)
An iv catheter will be inserted to draw blood during the 8-hour registration period. Blood samples, each witch a maximum volume of 10 mL, will be taken every 30 minutes to measure motilin and PP as surrogate markers of vagal efferent influence on GI motor function. In addition, autonomic parameters will be registered during the entire test period, using a Shimmer3 GSR sensor. After the 8-hour test period, the manometry catheter, the electrodes of the tVNS device and the iv cannula are removed.
Additionally, participants may opt to take part in a body surface gastric mapping assessment. This non-invasive, electrophysiological measurement is performed using the Gastric Alimetry system, which involves placing a large adhesive patch with multiple electrodes on the upper abdomen. The system records gastric myoelectrical activity over time, providing insight into gastric motility patterns. The measurement is conducted concurrently with the manometry registration period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Auricular Vagal Nerve Stimulation | Active comparator | Device: Vagal Nerve StimulationTaVNS |
| Sham stimulation | Placebo comparator | Device: Sham stimulationSham stimulation with a non-conducting electrode |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagal Nerve StimulationtaVNS will be provided during a 4-hour block of the 8-hour fasted antroduodenal manometry recording period. | Device | Transcutaneous Auricular Vagal Nerve Stimulation |
| Sham stimulationSham stimulation will be provided during a 4-hour block of the 8-hour fasted antroduodenal manometry recording period. | Device | Sham stimulation |
Primary outcome
A clinically meaningful increase in phase III contractions
Time frame: Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)
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.
5 secondary outcomes
A clinically relevant increase in other upper GI motility parameters
Time frame: Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)
Concentration of plasma motilin and pancreatic polypeptide
Time frame: Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)
Autonomic response: heart rate variability
Time frame: Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)
Electrodermal response: skin conductance
Time frame: Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)
Agreement between gastric motility measurements obtained by antroduodenal manometry and Gastric Alimetry
Time frame: Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Keszthelyi, MD, PhD principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagal Nerve Stimulation in people with Healthy Adult Participants, run by Daniel Keszthelyi at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Hawinkels, MD (+31883887808, kimberly.hawinkels@maastrichtuniversity.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A clinically meaningful increase in phase III contractions (time frame: Assessed during one single test day, from pre-intervention baseline to post-stimulation (approximately 8-9 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.