[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643592":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":56,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":67,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":26,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Academisch Ziekenhuis Maastricht","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcutaneous Auricular Vagal Nerve Stimulation","ACTIVE_COMPARATOR","TaVNS",[13],"Device: Vagal Nerve Stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham stimulation","PLACEBO_COMPARATOR","Sham stimulation with a non-conducting electrode",[19],"Device: Sham stimulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Vagal Nerve Stimulation","taVNS will be provided during a 4-hour block of the 8-hour fasted antroduodenal manometry recording period.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Sham stimulation will be provided during a 4-hour block of the 8-hour fasted antroduodenal manometry recording period.",[15],[31],{"name":32,"affiliation":33,"role":34},"Daniel Keszthelyi, MD, PhD","Maastricht University Medical Center","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Kimberly Hawinkels, MD","CONTACT","+31883887808","kimberly.hawinkels@maastrichtuniversity.nl",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":26},"Maastricht University","RECRUITING","Maastricht","Limburg","6229ER","Netherlands","NL",{"type":51,"coordinates":52},"Point",[53,54],5.68889,50.84833,{"lat":54,"lon":53},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Daniel Keszthelyi","Prof. Dr. Keszthelyi","100643592","the-effect-of-tavns-and-upper-gi-motility-100643592",false,"NCT07632378","The Effect of taVNS and Upper GI Motility","The Effect of Non-invasive Transauricular Vagus Nerve Stimulation on Upper Gastrointestinal Motility in Healthy Individuals","Inclusion Criteria:\n\n* Healthy participants (defined as those without a pre-existing medical comorbidity, including those without a history of cardiac arrhythmia).\n* Age between 18 and 55 years.\n* Ability to understand and speak the Dutch language.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Use of any substances (such as medication or recreational drugs) influencing gastrointestinal motility\n* Not meeting the inclusion criteria above.\n* 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.",true,"ALL","18 Years","55 Years",{"count":72,"type":73},12,"ESTIMATED","INTERVENTIONAL",[76],"NA","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.\n\nThe 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.\n\nSecondary objectives include:\n\n* 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\n* To study the effect of tVNS on plasma levels of motilin and PP\n* To evaluate the effect of tVNS on parameters related to autonomic outflow, using a Shimmer3 GSR Sensor for heart rate variability and skin conductance.\n* To compare the results of the measurements of antroduodenal manometry with measurements of Gastric Alimetry\n\nParticipants 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.",[79],"Healthy Adult Participants",[23,81,82,83,84],"Upper GI motility","Randomised Controlled Trial","Antroduodenal Manometry","Gastric Alimetry","2026-06-02",{"date":87,"type":88},"2026-06-08","ACTUAL",{"date":90,"type":88},"2025-02-25",{"date":92,"type":73},"2026-06",{"name":58,"class":6},1]