protocolSection identificationModule nctId: NCT06389175, orgStudyIdInfo id: BON001, secondaryIdInfos id: KR 4555/10-1, type: OTHER_GRANT, domain: Deutsche Forschungsgemeinschaft (DFG), briefTitle: Non-invasive Vagus Nerve Stimulation as a Tool to Modulate Stomach-Brain Coupling in Depression, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2026-12, completionDateStruct date: 2026-12, studyFirstPostDateStruct date: 2024-04-29, lastUpdatePostDateStruct date: 2024-04-29, sponsorCollaboratorsModule leadSponsor name: University of Bonn, class: OTHER, collaborators name: University Hospital Tuebingen, descriptionModule briefSummary: The overarching goal of the project is to determine whether differences in stomach-brain coupling contribute to key symptoms of major depressive disorder (MDD) and whether transcutaneous non-invasive vagus nerve stimulation (tVNS) may serve as a non-invasive intervention to improve aberrant interoceptive signaling in participants suffering from MDD., conditionsModule conditions: Depressive Disorder, Major, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Transcutaneous non-invasive vagus nerve stimulation (tVNS), interventions name: Sham stimulation, outcomesModule primaryOutcomes measure: Stimulation-induced acute changes in stomach-brain coupling, primaryOutcomes measure: Stimulation-induced acute changes in gastric motility, primaryOutcomes measure: Stimulation-induced mid-term changes in gastric motility, primaryOutcomes measure: Stimulation-induced mid-term changes in self-reported interoception, primaryOutcomes measure: Stimulation-induced mid-term changes in somatic symptoms, primaryOutcomes measure: Stimulation-induced mid-term changes in depressive symptoms, primaryOutcomes measure: Stimulation-induced acute neural changes in food cue reactivity, primaryOutcomes measure: Stimulation-induced acute behavioral changes in invigoration, primaryOutcomes measure: Stimulation-induced acute neural changes during foraging, primaryOutcomes measure: Stimulation-induced acute behavioral changes in foraging decisions, secondaryOutcomes measure: Stimulation-induced mid-term changes in positive and negative affect, secondaryOutcomes measure: Stimulation-induced mid-term changes in self-reported interoception, secondaryOutcomes measure: Stimulation-induced mid-term changes in motivation, secondaryOutcomes measure: Stimulation-induced mid-term changes in physical activity, secondaryOutcomes measure: Stimulation-induced mid-term changes in heart rate, secondaryOutcomes measure: Stimulation-induced acute changes in blood parameters, secondaryOutcomes measure: Stimulation-induced mid-term changes in blood parameters, secondaryOutcomes measure: Stimulation-induced mid-term changes in composition of microbiome, otherOutcomes measure: Stimulation-induced mid-term changes in discounting-related decision-making, otherOutcomes measure: Stimulation-induced mid-term changes in reward learning, otherOutcomes measure: Stimulation-induced mid-term changes in loneliness, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False