Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy SubjectsNCT02139293
Pilot Study - Auricular Vagus Nerve Stimulation Effects on Cardiovascular Parameters
A study testing PrimeStim in people with Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects
- What is being tested?
- PrimeStim
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- men and women aged 20 to 50 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Stefan Kampusch, MSc contact
Austria1 site
University Clinic for Surgery, Department of Transplantation, Medical University Vienna
Vienna, 1090
Jozsef C Széles, Dr.med., +4367687832013, jozsef.szeles@meduniwien.ac.at
Jozsef C Széles, Dr.med.
About this study
Official title: Functional Mapping of Auricular Vagal Stimulation Points on Cardiovascular Parameters in Healthy Subjects - Pilot Study
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.
- Being tested
- PrimeStim
- Keywords
- vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrimeStimDevice
Intermittent auricular vagus nerve stimulation at different ear points
| Study group | Role | What they receive |
|---|---|---|
| auricular vagus nerve stimulation | Experimental | 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. Receives: Device: PrimeStim |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in heart rate variability (HRV) related to stimulation site in the auricle
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.
Measured: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
change in local blood perfusion index (BPI) related to stimulation site in the auricle
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.
Measured: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Secondary outcomes (10)
Change of local BPI in upper and lower extremities
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.
Measured: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in blood pressure
Blood pressure is continuously measured using inflatable finger cuffs.
Measured: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in respiratory activity
Respiratory activity is monitored using a respiratory belt.
Measured: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in oxygen saturation of the toe
Measured: 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
Measured: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in foot skin temperature
Measured: 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
Measured: at screening and at the last day of intervention
Tolerance of stimulation
Tolerance of stimulation is assessed by free survey.
Measured: at each day of intervention at the stimulation cycles
Perception of Stimulation
Perception of stimulation is assessed by free survey.
Measured: at each day of intervention at the stiumulation cycles
Adverse effects of stimulation
Measured: within 4 days of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startJan 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Vienna University of Technology
- Responsible party
- Principal investigator, Dr. Jozsef Constantin Széles, Medical University of Vienna
- Investigators
- Jozsef C Széles, Dr.med., Principal investigator, University Clinic for Surgery, Department of Transplantation, Medical University Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139293
- Sponsor's protocol ID
- PS 02/2014
- Status last verified
- Sep 2017
- First submitted
- 13 May 2014
- Last updated
- 5 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Mapping of Auricular Vagal Stimulation Points on Cardiovascular Parameters in Healthy Subjects - Pilot Study
- ClinicalTrials.gov ID
- NCT02139293
- Acronym / sponsor ID
- PS 02/2014
- Keywords
- vagus nerve stimulation effects on heart rate variability and peripheral blood perfusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Vienna University of Technology
- Study start
- Jan 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 15 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| auricular vagus nerve stimulation | Experimental | Device: PrimeStimStudy 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- men and women aged 20 to 50 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrimeStimIntermittent auricular vagus nerve stimulation at different ear points | Device | auricular vagus nerve stimulation |
Primary outcome
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.
10 secondary outcomes
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
Changes in blood pressure
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
Changes in respiratory activity
Time frame: within 4 days of intervention, at each day of intervention from baseline to stimulation and pause cycles
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
Perception of Stimulation
Time frame: at each day of intervention at the stiumulation cycles
Adverse effects of stimulation
Time frame: within 4 days of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Kampusch, MSc contact
Jozsef C Széles, Dr.med. principal investigator
University Clinic for Surgery, Department of Transplantation, Medical University Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrimeStim in people with Modulation of Cardiovascular Parameters and Sympathovagal Balance in Healthy Subjects, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jozsef C Széles, Dr.med. (+4367687832013, jozsef.szeles@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.