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Pilot Study - Auricular Vagus Nerve Stimulation Effects on Cardiovascular Parameters

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ClinicalTrials.gov Identifier: NCT02139293
Recruitment Status : Unknown
Verified September 2017 by Dr. Jozsef Constantin Széles, Medical University of Vienna.
Recruitment status was:  Not yet recruiting
First Posted : May 15, 2014
Last Update Posted : September 5, 2017
Sponsor:
Collaborator:
Vienna University of Technology
Information provided by (Responsible Party):
Dr. Jozsef Constantin Széles, Medical University of Vienna

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects Device: PrimeStim Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Functional Mapping of Auricular Vagal Stimulation Points on Cardiovascular Parameters in Healthy Subjects - Pilot Study
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.

 Device: PrimeStim
Intermittent auricular vagus nerve stimulation at different ear points


Outcome Measures
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Primary Outcome Measures :
  1. change in heart rate variability (HRV) related to stimulation site in the auricle [ Time Frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles ]

    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.

    Changes in assessed heart rate variability parameters will be assessed and compared between subjects with respect to stimulation site using statistical tests.


  2. change in local blood perfusion index (BPI) related to stimulation site in the auricle [ Time Frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles ]

    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.

    Changes 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.



Secondary Outcome Measures :
  1. Change of local BPI in upper and lower extremities [ Time Frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles ]

    Local BPI is assessed using optical sensors on the foot and the finger of participants.

    Changes in mean value of BPI are analyzed using statistical tests.


  2. Changes in blood pressure [ Time Frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles ]
    Blood pressure is continuously measured using inflatable finger cuffs.

  3. Changes in respiratory activity [ Time Frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles ]
    Respiratory activity is monitored using a respiratory belt.

  4. Changes in oxygen saturation of the toe [ Time Frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles ]
  5. Changes in partial transcutaneous oxygen pressure of the forefoot [ Time Frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles ]
  6. Changes in foot skin temperature [ Time Frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles ]
  7. Changes of C reactive protein- and leukocyte-concentration in serum [ Time Frame: at screening and at the last day of intervention ]
  8. Tolerance of stimulation [ Time Frame: at each day of intervention at the stimulation cycles ]
    Tolerance of stimulation is assessed by free survey.

  9. Perception of Stimulation [ Time Frame: at each day of intervention at the stiumulation cycles ]
    Perception of stimulation is assessed by free survey.

  10. Adverse effects of stimulation [ Time Frame: within 4 days of intervention ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • men and women aged 20 to 50 years

Exclusion Criteria:

  • participation in a clinical trial in the last 5 weeks
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139293


Contacts
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Contact: Jozsef C Széles, Dr.med. +4367687832013 jozsef.szeles@meduniwien.ac.at
Contact: Stefan Kampusch, MSc stefan.kampusch@tuwien.ac.at

Locations
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Austria
University Clinic for Surgery, Department of Transplantation, Medical University Vienna
Vienna, Austria, 1090
Contact: Jozsef C Széles, Dr.med.    +4367687832013    jozsef.szeles@meduniwien.ac.at   
Principal Investigator: Jozsef C Széles, Dr.med.         
Sub-Investigator: Eugenijus Kaniusas, Prof.         
Sub-Investigator: Stefan Kampusch, MSc         
Sponsors and Collaborators
Medical University of Vienna
Vienna University of Technology
Investigators
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Principal Investigator: Jozsef C Széles, Dr.med. University Clinic for Surgery, Department of Transplantation, Medical University Vienna
More Information
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Responsible Party: Dr. Jozsef Constantin Széles, Dr.med., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT02139293    
Other Study ID Numbers: PS 02/2014
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Jozsef Constantin Széles, Medical University of Vienna:
vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion