Pilot Study - Auricular Vagus Nerve Stimulation Effects on Cardiovascular Parameters
NCT ID: NCT02139293
Last Updated: 2017-09-05
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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UNKNOWN
NA
10 participants
INTERVENTIONAL
2018-01-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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auricular vagus nerve stimulation
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.
Stimulation 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.
During the described protocol various biosignals are continuously recorded, including ECG, respiration, blood perfusion, oxygen saturation, transcutaneous oxygen tension, blood pressure and skin temperature.
PrimeStim
Intermittent auricular vagus nerve stimulation at different ear points
Interventions
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PrimeStim
Intermittent auricular vagus nerve stimulation at different ear points
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* diseases which may affect the autonomous nervous system (e.g., diabetes mellitus)
* confounding medical treatment with known effects on the autonomous nervous system (e.g., beta blocker)
* drug abuse
* active implanted devices
* pregnancy or nursing
20 Years
50 Years
ALL
Yes
Sponsors
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Vienna University of Technology
OTHER
Medical University of Vienna
OTHER
Responsible Party
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Dr. Jozsef Constantin Széles
Dr.med.
Principal Investigators
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Jozsef C Széles, Dr.med.
Role: PRINCIPAL_INVESTIGATOR
University Clinic for Surgery, Department of Transplantation, Medical University Vienna
Locations
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University Clinic for Surgery, Department of Transplantation, Medical University Vienna
Vienna, , Austria
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PS 02/2014
Identifier Type: -
Identifier Source: org_study_id
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