Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-03-03 @ 2:20 AM
Study NCT ID:
NCT02139293
Status:
UNKNOWN
Last Update Posted:
2017-09-05
First Post:
2014-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study - Auricular Vagus Nerve Stimulation Effects on Cardiovascular Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-01', 'studyFirstSubmitDate': '2014-05-13', 'studyFirstSubmitQcDate': '2014-05-13', 'lastUpdatePostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in heart rate variability (HRV) related to stimulation site in the auricle', 'timeFrame': 'within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles', 'description': 'Heart rate variability will be assessed as, e.g., standard deviation in heart rate over a time window of 5 minutes (2.5 minutes overlap), total power or low to high frequency power.\n\nChanges in assessed heart rate variability parameters will be assessed and compared between subjects with respect to stimulation site using statistical tests.'}, {'measure': 'change in local blood perfusion index (BPI) related to stimulation site in the auricle', 'timeFrame': 'within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles', 'description': 'Blood perfusion index at the foot will be assessed as peak-peak amplitude (systolic to diastolic) divided by the mean signal value of optically measured blood perfusion.\n\nChanges in mean value and standard deviation of local blood perfusion index will be assessed and compared between subjects with respect to stimulation site using statistical tests.'}], 'secondaryOutcomes': [{'measure': 'Change of local BPI in upper and lower extremities', 'timeFrame': 'within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles', 'description': 'Local BPI is assessed using optical sensors on the foot and the finger of participants.\n\nChanges in mean value of BPI are analyzed using statistical tests.'}, {'measure': 'Changes in blood pressure', 'timeFrame': 'within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles', 'description': 'Blood pressure is continuously measured using inflatable finger cuffs.'}, {'measure': 'Changes in respiratory activity', 'timeFrame': 'within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles', 'description': 'Respiratory activity is monitored using a respiratory belt.'}, {'measure': 'Changes in oxygen saturation of the toe', 'timeFrame': 'within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles'}, {'measure': 'Changes in partial transcutaneous oxygen pressure of the forefoot', 'timeFrame': 'within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles'}, {'measure': 'Changes in foot skin temperature', 'timeFrame': 'within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles'}, {'measure': 'Changes of C reactive protein- and leukocyte-concentration in serum', 'timeFrame': 'at screening and at the last day of intervention'}, {'measure': 'Tolerance of stimulation', 'timeFrame': 'at each day of intervention at the stimulation cycles', 'description': 'Tolerance of stimulation is assessed by free survey.'}, {'measure': 'Perception of Stimulation', 'timeFrame': 'at each day of intervention at the stiumulation cycles', 'description': 'Perception of stimulation is assessed by free survey.'}, {'measure': 'Adverse effects of stimulation', 'timeFrame': 'within 4 days of intervention'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion'], 'conditions': ['Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous system stimulation on cardiovascular parameters and sympathovagal balance in healthy subjects. It is investigated if auricular vagal nerve stimulation affects heart rate variability as well as peripheral local blood perfusion, and if this effect depends on the site of stimulation in the auricle, whereas four distinct stimulation points are tested.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women aged 20 to 50 years\n\nExclusion Criteria:\n\n* participation in a clinical trial in the last 5 weeks\n* diseases which may affect the autonomous nervous system (e.g., diabetes mellitus)\n* confounding medical treatment with known effects on the autonomous nervous system (e.g., beta blocker)\n* drug abuse\n* active implanted devices\n* pregnancy or nursing'}, 'identificationModule': {'nctId': 'NCT02139293', 'briefTitle': 'Pilot Study - Auricular Vagus Nerve Stimulation Effects on Cardiovascular Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Functional Mapping of Auricular Vagal Stimulation Points on Cardiovascular Parameters in Healthy Subjects - Pilot Study', 'orgStudyIdInfo': {'id': 'PS 02/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'auricular vagus nerve stimulation', 'description': 'Study participants (healthy) are treated with auricular vagus nerve stimulation using five needle electrodes connected to an electrical stimulation device (PrimeStim). After acclimatization the stimulation is turned on for 20 minutes followed by 20 minutes of paused stimulation, 20 minutes of stimulation, and 10 minutes paused stimulation. This intervention is repeated on four consecutive days, whereas at each intervention only one of the four stimulation points (and one fixed reference point) is stimulated. Needle electrodes are applied at each study visit.\n\nStimulation points in the auricle are stimulated in random order. One stimulation pattern is tested. Stimulation amplitudes are adjusted with respect to a distinct but comfortable sensation at the auricle.\n\nDuring the described protocol various biosignals are continuously recorded, including ECG, respiration, blood perfusion, oxygen saturation, transcutaneous oxygen tension, blood pressure and skin temperature.', 'interventionNames': ['Device: PrimeStim']}], 'interventions': [{'name': 'PrimeStim', 'type': 'DEVICE', 'description': 'Intermittent auricular vagus nerve stimulation at different ear points', 'armGroupLabels': ['auricular vagus nerve stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'contacts': [{'name': 'Jozsef C Széles, Dr.med.', 'role': 'CONTACT', 'email': 'jozsef.szeles@meduniwien.ac.at', 'phone': '+4367687832013'}, {'name': 'Jozsef C Széles, Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Eugenijus Kaniusas, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Stefan Kampusch, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Clinic for Surgery, Department of Transplantation, Medical University Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Jozsef C Széles, Dr.med.', 'role': 'CONTACT', 'email': 'jozsef.szeles@meduniwien.ac.at', 'phone': '+4367687832013'}, {'name': 'Stefan Kampusch, MSc', 'role': 'CONTACT', 'email': 'stefan.kampusch@tuwien.ac.at'}], 'overallOfficials': [{'name': 'Jozsef C Széles, Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Clinic for Surgery, Department of Transplantation, Medical University Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vienna University of Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.med.', 'investigatorFullName': 'Dr. Jozsef Constantin Széles', 'investigatorAffiliation': 'Medical University of Vienna'}}}}