Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-28 @ 12:57 PM
Study NCT ID:
NCT04890457
Status:
UNKNOWN
Last Update Posted:
2021-06-30
First Post:
2021-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain, Behavior and Endocrine Effects of Transcutaneous Vagus Nerve Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-28', 'studyFirstSubmitDate': '2021-05-12', 'studyFirstSubmitQcDate': '2021-05-16', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxytocin release', 'timeFrame': 'After 30 min tragus stimulation', 'description': 'Investigating the oxytocin release after vagus nerve stimulation via tragus based on saliva samples'}], 'secondaryOutcomes': [{'measure': 'The relationship between oxytocin concentration and personal traits', 'timeFrame': 'through study completion, an average of half an year', 'description': 'Analyzing the correlation between saliva oxytocin concentration and scores on different personal traits'}, {'measure': 'Pupil size', 'timeFrame': 'After 30 min tragus stimulation', 'description': 'Investigating whether vagus nerve stimulation via tragus will increase pupil diameter'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcutaneous vagus nerve stimulation', 'Oxytocin release', 'Eye-tracking'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main aim of the study is to investigate whether the transcutaneous vagus nerve stimulation(tVNS) promotes oxytocin release and the potential biomarkers of tVNS based on eye-tracking data', 'detailedDescription': "A randomized, single-blinded, sham-controlled, within-subject, crossover design will be employed in this study. In a randomized order, a total of 54 healthy subjects will receive transcutaneous vagus nerve stimulation via tragus and sham stimulation vis earlobe in the left ear (interval between these two stimulations will be 1 week). Eye-tracking and behavioral data will be collected before and after 30 minutes of stimulation, saliva samples will be collected before and after 30 minutes of stimulation, and the end of the experiment.\n\nSome personal traits will be assessed using different kinds of questionnaires, such as the Autism Spectrum Quotient(ASQ), Social Responsiveness Scale(SRS), State-Trait Anxiety Inventory (STAI), Beck's Depression Inventory(BDI), and Toronto Alexithymia Scale (TAS-20)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects without past or current psychiatric or neurological disorders\n\nExclusion Criteria:\n\n* history of head injury;\n* pregnant, menstruating, taking oral contraceptives;\n* medical or psychiatric illness.'}, 'identificationModule': {'nctId': 'NCT04890457', 'briefTitle': 'Brain, Behavior and Endocrine Effects of Transcutaneous Vagus Nerve Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Electronic Science and Technology of China'}, 'officialTitle': 'Transcutaneous Vagus Nerve Stimulation Promotes Oxytocin Release and Increases Fixations on Nose', 'orgStudyIdInfo': {'id': 'UESTC-neuSCAN-81'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tragus then earlobe stimulation', 'interventionNames': ['Device: Vagus nerve stimulation via tragus', 'Device: Sham stimulation via earlobe']}, {'type': 'EXPERIMENTAL', 'label': 'Earlobe then tragus stimulation', 'interventionNames': ['Device: Vagus nerve stimulation via tragus', 'Device: Sham stimulation via earlobe']}], 'interventions': [{'name': 'Vagus nerve stimulation via tragus', 'type': 'DEVICE', 'description': "The device will send stimulus intensity around 0.5mA via tragus in the left ear (based on participants' subjective report), delivered with a pulse width of 0.25 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds.", 'armGroupLabels': ['Earlobe then tragus stimulation', 'Tragus then earlobe stimulation']}, {'name': 'Sham stimulation via earlobe', 'type': 'DEVICE', 'description': "The device will send stimulus intensity around 0.5mA via earlobe in the left ear (based on participants' subjective report), delivered with a pulse width of 0.25 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds.", 'armGroupLabels': ['Earlobe then tragus stimulation', 'Tragus then earlobe stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '611731', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Siyu Zhu, M.S.', 'role': 'CONTACT', 'email': 'thelmalo@outlook.com', 'phone': '86-13398406275'}, {'name': 'Qin Li, Dr.', 'role': 'CONTACT', 'email': 'helenlee@uestc.edu.cn', 'phone': '86-28-61830811'}], 'facility': 'University of Electronic Science and Technology of China', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Keith Kendrick, Dr.', 'role': 'CONTACT', 'email': 'k.kendrick.uestc@gmail.com', 'phone': '86-28-61830811'}, {'name': 'Benjamin Becker, Dr.', 'role': 'CONTACT', 'email': 'ben_becker@gmx.de', 'phone': '86-28-61830988'}], 'overallOfficials': [{'name': 'Keith Kendrick, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Electronic Science and Technology of China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Electronic Science and Technology of China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Keith Kendrick', 'investigatorAffiliation': 'University of Electronic Science and Technology of China'}}}}