AzTrials
AzTrials

Vagus Nerve StimulationNCT06086236

Vagus Nerve Stimulation Effects on Autonomic Nervous System Activity

A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Vagus Nerve Stimulation, run by Bahçeşehir University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Transcutaneous Auricular Vagus nerve stimulation may be successful in cardiac modulation because of the cardiac connections of the vagal nerve. Therefore, in order to observe the cardiac effects, it was analysed the changes in pulse rate, systolic and diastolic blood pressure after transcutaneous auricular vagus nerve… Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Vagus Nerve Stimulation
What is being tested?
Transcutaneous Auricular Vagus Nerve Stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2023to 10 Sep 2023
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 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age between 18 and 40 years old.
  • No previous vagus nerve stimulation

Who cannot join

  • Using of any drug, alcohol or smoking.
  • Pregnancy.
  • Known history of acute or chronic illness.
  • Being in the post or peri-menopausal stage.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Igdir University

    Iğdır, Merkez, 76000

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Basic Autonomic Nervous System Activity

Transcutaneous Auricular Vagus nerve stimulation may be successful in cardiac modulation because of the cardiac connections of the vagal nerve. Therefore, in order to observe the cardiac effects, it was analysed the changes in pulse rate, systolic and diastolic blood pressure after transcutaneous auricular vagus nerve stimulation application.

Read the detailed description

Participants were divided into four groups (Figure 1) according to PNS and SNS indexes as Group 1 (PNS index <-2, SNS index >+2), Group 2 (PNS index <-2, SNS index <+2), Group 3 (PNS index >-2, SNS index >+2), Group 4 (PNS index >-2, SNS index <+2). Participants were assessed with blood pressure, pulse rate and HRV before and after taVNS stimulation. Sympathetic nervous system (SNS) index and parasympathetic nervous system (PNS) index values were assumed to be between -2 and +2 (95%) in the normal population according to Kubios software, and the grouping method was based on this situation.

Being tested
Transcutaneous Auricular Vagus Nerve Stimulation
Keywords
Vagus Nerve Stimulations, Diastolic Pressure, Pulse Rate, Systolic Pressure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcutaneous Auricular Vagus Nerve StimulationDevice

    Through a special Ear set, bilateral Transcutaneous Auricular Vagus Nerve Stimulation was applied to all participants for 20 minutes.

Study groups in NCT06086236
Study groupRoleWhat they receive
PNS Index<-2 and SNS Index>2ExperimentalParticipants with Parasympathetic Nervous System (PNS) and Sympathetic Nervous System (SNS) Indexes values ''PNS<-2, SNS>2'' according to the results of heart rate variability measurements were included in this group. Then bilateral transcutaneous auricular vagus nerve stimulation was performed.
Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation
PNS Index<-2 and SNS Index<2ExperimentalParticipants with Parasympathetic Nervous System (PNS) and Sympathetic Nervous System (SNS) Indexes values ''PNS<-2, SNS<2'' according to the results of heart rate variability measurements were included in this group. Then bilateral transcutaneous auricular vagus nerve stimulation was performed.
Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation
PNS Index>-2 and SNS Index>2ExperimentalParticipants with Parasympathetic Nervous System (PNS) and Sympathetic Nervous System (SNS) Indexes values ''PNS>-2, SNS>2'' according to the results of heart rate variability measurements were included in this group. Then bilateral transcutaneous auricular vagus nerve stimulation was performed.
Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation
PNS Index>-2 and SNS Index<2ExperimentalParticipants with Parasympathetic Nervous System (PNS) and Sympathetic Nervous System (SNS) Indexes values ''PNS>-2, SNS<2'' according to the results of heart rate variability measurements were included in this group. Then bilateral transcutaneous auricular vagus nerve stimulation was performed.
Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulse Rate

    The pulse rate of the participants was measured with an electronic blood pressure monitor.

    Measured: Up to 6 Months

  2. Systolic Blood Pressure

    The systolic blood pressure of the participants was measured with an electronic blood pressure monitor.

    Measured: Up to 6 Months

  3. Diastolic Blood Pressure

    The diastolic blood pressure of the participants was measured with an electronic blood pressure monitor.

    Measured: Up to 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2023
  2. Study start1 Apr 2023
  3. Primary completion1 Sep 2023
  4. Study completion10 Sep 2023

Resources

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
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
After the participants were included in the study, heart rate variability was measured and divided into 4 groups according to PNS and SNS indexes.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06086236
Sponsor's protocol ID
AP00013
Status last verified
Oct 2023
First submitted
6 Oct 2023
Last updated
17 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: It is not preferred to share the data until the study is published.

Publications

  • Wang Y, Li SY, Wang D, Wu MZ, He JK, Zhang JL, Zhao B, Hou LW, Wang JY, Wang L, Wang YF, Zhang Y, Zhang ZX, Rong PJ. Transcutaneous Auricular Vagus Nerve Stimulation: From Concept to Application. Neurosci Bull. 2021 Jun;37(6):853-862. doi: 10.1007/s12264-020-00619-y. Epub 2020 Dec 23.

    PubMed 33355897

  • Ben-Menachem E, Revesz D, Simon BJ, Silberstein S. Surgically implanted and non-invasive vagus nerve stimulation: a review of efficacy, safety and tolerability. Eur J Neurol. 2015 Sep;22(9):1260-8. doi: 10.1111/ene.12629. Epub 2015 Jan 23.

    PubMed 25614179

  • Milby AH, Halpern CH, Baltuch GH. Vagus nerve stimulation for epilepsy and depression. Neurotherapeutics. 2008 Jan;5(1):75-85. doi: 10.1016/j.nurt.2007.10.071.

    PubMed 18164486

  • Butt MF, Albusoda A, Farmer AD, Aziz Q. The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat. 2020 Apr;236(4):588-611. doi: 10.1111/joa.13122. Epub 2019 Nov 19.

    PubMed 31742681

  • Borovikova LV, Ivanova S, Zhang M, Yang H, Botchkina GI, Watkins LR, Wang H, Abumrad N, Eaton JW, Tracey KJ. Vagus nerve stimulation attenuates the systemic inflammatory response to endotoxin. Nature. 2000 May 25;405(6785):458-62. doi: 10.1038/35013070.

    PubMed 10839541

  • Sinniger V, Pellissier S, Fauvelle F, Trocme C, Hoffmann D, Vercueil L, Cracowski JL, David O, Bonaz B. A 12-month pilot study outcomes of vagus nerve stimulation in Crohn's disease. Neurogastroenterol Motil. 2020 Oct;32(10):e13911. doi: 10.1111/nmo.13911. Epub 2020 Jun 8.

    PubMed 32515156

  • Sigurdsson HP, Raw R, Hunter H, Baker MR, Taylor JP, Rochester L, Yarnall AJ. Noninvasive vagus nerve stimulation in Parkinson's disease: current status and future prospects. Expert Rev Med Devices. 2021 Oct;18(10):971-984. doi: 10.1080/17434440.2021.1969913. Epub 2021 Sep 8.

    PubMed 34461787

  • Badran BW, Dowdle LT, Mithoefer OJ, LaBate NT, Coatsworth J, Brown JC, DeVries WH, Austelle CW, McTeague LM, George MS. Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Brain Stimul. 2018 May-Jun;11(3):492-500. doi: 10.1016/j.brs.2017.12.009. Epub 2017 Dec 29.

    PubMed 29361441

  • Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A. Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23.

    PubMed 30217648

  • Sclocco R, Garcia RG, Kettner NW, Isenburg K, Fisher HP, Hubbard CS, Ay I, Polimeni JR, Goldstein J, Makris N, Toschi N, Barbieri R, Napadow V. The influence of respiration on brainstem and cardiovagal response to auricular vagus nerve stimulation: A multimodal ultrahigh-field (7T) fMRI study. Brain Stimul. 2019 Jul-Aug;12(4):911-921. doi: 10.1016/j.brs.2019.02.003. Epub 2019 Feb 10.

    PubMed 30803865

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Vagus Nerve Stimulation, run by Bahçeşehir University at 1 site in Turkey (Türkiye).

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 2 inclusion and 4 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: finished, as of the sponsor's last update on 17 Oct 2023. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulse Rate (time frame: Up to 6 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06086236, which also lists 10 linked publications.

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 17 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in