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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

Tracking Information
First Submitted Date  ICMJE May 13, 2014
First Posted Date  ICMJE May 15, 2014
Last Update Posted Date September 5, 2017
Estimated Study Start Date  ICMJE January 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
  • change in heart rate variability (HRV) related to stimulation site in the auricle [ Time Frame: within 4 days of intervention ]
    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.
  • change in local blood perfusion index (BPI) related to stimulation site in the auricle [ Time Frame: within 4 days of intervention ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2014)
  • 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.
  • 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.
  • 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.
  • 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 ]
  • 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 ]
  • Changes in foot skin temperature [ Time Frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles ]
  • Changes of C reactive protein- and leukocyte-concentration in serum [ Time Frame: at screening and at the last day of intervention ]
  • Tolerance of stimulation [ Time Frame: at each day of intervention at the stimulation cycles ]
    Tolerance of stimulation is assessed by free survey.
  • Perception of Stimulation [ Time Frame: at each day of intervention at the stiumulation cycles ]
    Perception of stimulation is assessed by free survey.
  • Adverse effects of stimulation [ Time Frame: within 4 days of intervention ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
  • Change of local BPI in upper and lower extremities [ Time Frame: within 4 days of intervention ]
    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.
  • Changes in blood pressure [ Time Frame: within 4 days of intervention ]
    Blood pressure is continuously measured using inflatable finger cuffs.
  • Changes in respiratory activity [ Time Frame: within 4 days of intervention ]
    Respiratory activity is monitored using a respiratory belt.
  • Changes in oxygen saturation of the toe [ Time Frame: within 4 days of intervention ]
  • Changes in partial transcutaneous oxygen pressure of the forefoot [ Time Frame: within 4 days of intervention ]
  • Changes in foot skin temperature [ Time Frame: within 4 days of intervention ]
  • Changes of C reactive protein- and leukocyte-concentration in serum [ Time Frame: within 4 days of intervention ]
  • Tolerance of stimulation [ Time Frame: within 4 days of intervention ]
    Tolerance of stimulation is assessed by free survey.
  • Perception of Stimulation [ Time Frame: within 4 days of intervention ]
    Perception of stimulation is assessed by free survey.
  • Adverse effects of stimulation [ Time Frame: within 4 days of intervention ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study - Auricular Vagus Nerve Stimulation Effects on Cardiovascular Parameters
Official Title  ICMJE Functional Mapping of Auricular Vagal Stimulation Points on Cardiovascular Parameters in Healthy Subjects - Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects
Intervention  ICMJE Device: PrimeStim
Intermittent auricular vagus nerve stimulation at different ear points
Study Arms  ICMJE 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.

Intervention: Device: PrimeStim
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 13, 2014)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02139293
Other Study ID Numbers  ICMJE PS 02/2014
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Jozsef Constantin Széles, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Vienna University of Technology
Investigators  ICMJE
Principal Investigator: Jozsef C Széles, Dr.med. University Clinic for Surgery, Department of Transplantation, Medical University Vienna
PRS Account Medical University of Vienna
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP