Testing the Noradrenergic Hypothesis of Transcutaneous Vagus Nerve Stimulation
NCT ID: NCT04455295
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
55 participants
INTERVENTIONAL
2020-09-01
2025-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Active Stimulation 0.5
0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles.
Transdermal Vagus Nerve Stimulation (tVNS)
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.
Lobe Control
0.5mA, 30Hz intermittent transdermal vagus nerve stimulation of the earlobe. Stimulation 30 second on/30 seconds off for five cycles.
Transdermal Vagus Nerve Stimulation (tVNS)
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.
Sham Stimulation
0.5mA, 5Hz intermittent transdermal vagus nerve stimulation of the auricle vagus. Stimulation 30 second on/30 seconds off for five cycles.
Transdermal Vagus Nerve Stimulation (tVNS)
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.
Nonstimulation
Placement of electrode without any stimulation.
Transdermal Vagus Nerve Stimulation (tVNS)
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.
Interventions
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Transdermal Vagus Nerve Stimulation (tVNS)
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Arkansas Tech University
OTHER
Responsible Party
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Locations
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Arkansas Tech University
Russellville, Arkansas, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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Roosevelt_102218
Identifier Type: -
Identifier Source: org_study_id
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