Ignite Creation Date:
2025-12-24 @ 1:21 PM
Ignite Modification Date:
2025-12-30 @ 5:24 PM
Study NCT ID:
NCT04455295
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-28
First Post:
2020-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-27', 'size': 148127, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-02-28T15:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-23', 'studyFirstSubmitDate': '2020-06-29', 'studyFirstSubmitQcDate': '2020-06-29', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pupil Diameter', 'timeFrame': 'Within single one hour session', 'description': 'Pupil diameter is measured via camera.'}, {'measure': 'EEG Alpha power.', 'timeFrame': 'Within single one hour session', 'description': 'Alpha power will be determined from EEG.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['no Condition', 'Electroencephalography', 'Pupil Diameter']}, 'descriptionModule': {'briefSummary': 'This study investigates the capacity of non-invasive vagus nerve stimulation, applied at the ear, to alter to measures of locus coeruleus output pupil diameter and EEG alpha power. Non-invasive alteration in locus coeruleus output is of interest in regard to basic science and has potential clinical implications in a number of conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, 18 years of age or older.\n\nExclusion Criteria:\n\n* self-report of mood disorders, prescription and non-prescription drug use which includes stimulants including caffeine and nicotine'}, 'identificationModule': {'nctId': 'NCT04455295', 'briefTitle': 'Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'Arkansas Tech University'}, 'officialTitle': 'Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation', 'orgStudyIdInfo': {'id': 'Roosevelt_102218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Stimulation 0.5', 'description': '0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles.', 'interventionNames': ['Device: Transdermal Vagus Nerve Stimulation (tVNS)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Lobe Control', 'description': '0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the earlobe. Stimulation 30 second on/30 seconds off for five cycles.', 'interventionNames': ['Device: Transdermal Vagus Nerve Stimulation (tVNS)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sham Stimulation', 'description': '0.5mA, 5Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles.', 'interventionNames': ['Device: Transdermal Vagus Nerve Stimulation (tVNS)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Nonstimulation', 'description': 'Placement of electrode without any stimulation.', 'interventionNames': ['Device: Transdermal Vagus Nerve Stimulation (tVNS)']}], 'interventions': [{'name': 'Transdermal Vagus Nerve Stimulation (tVNS)', 'type': 'DEVICE', 'description': 'Mild non-invasive transdermal electrical stimulation at the ear (0.0-1.0 mA, 0.0-30.0 Hz). Used in previous studies with no unexpected adverse events. Stimulator not considered a FDA regulated device in previous studies.', 'armGroupLabels': ['Active Stimulation 0.5', 'Lobe Control', 'Nonstimulation', 'Sham Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72801', 'city': 'Russellville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Tech University', 'geoPoint': {'lat': 35.27842, 'lon': -93.13379}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arkansas Tech University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}