NCT06086236

Brief 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 stimulation application.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

5 months

First QC Date

October 6, 2023

Last Update Submit

October 13, 2023

Conditions

Vagus Nerve Stimulation

Keywords

Vagus Nerve StimulationsDiastolic PressurePulse RateSystolic Pressure

Outcome Measures

Primary Outcomes (3)

  • Pulse Rate

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

    Up to 6 Months

  • Systolic Blood Pressure

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

    Up to 6 Months

  • Diastolic Blood Pressure

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

    Up to 6 Months

Study Arms (4)

PNS Index<-2 and SNS Index>2

EXPERIMENTAL

Participants 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.

Device: Transcutaneous Auricular Vagus Nerve Stimulation

PNS Index<-2 and SNS Index<2

EXPERIMENTAL

Participants 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.

Device: Transcutaneous Auricular Vagus Nerve Stimulation

PNS Index>-2 and SNS Index>2

EXPERIMENTAL

Participants 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.

Device: Transcutaneous Auricular Vagus Nerve Stimulation

PNS Index>-2 and SNS Index<2

EXPERIMENTAL

Participants 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.

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Interventions

Transcutaneous Auricular Vagus Nerve StimulationDEVICE

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

PNS Index<-2 and SNS Index<2PNS Index<-2 and SNS Index>2PNS Index>-2 and SNS Index<2PNS Index>-2 and SNS Index>2

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Igdir University

Iğdır, Merkez, 76000, Turkey (Türkiye)

Location

Related Publications (10)

  • 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.

    PMID: 33355897BACKGROUND

  • 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.

    PMID: 25614179BACKGROUND

  • 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.

    PMID: 18164486BACKGROUND

  • 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.

    PMID: 31742681BACKGROUND

  • 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.

    PMID: 10839541BACKGROUND

  • 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.

    PMID: 32515156BACKGROUND

  • 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.

    PMID: 34461787BACKGROUND

  • 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.

    PMID: 29361441BACKGROUND

  • 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.

    PMID: 30217648BACKGROUND

  • 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.

    PMID: 30803865BACKGROUND

Study Officials

  • Alper Perçin, Ph.D.

    Igdir University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The evaluations were carried out by the second researcher
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: After the participants were included in the study, heart rate variability was measured and divided into 4 groups according to PNS and SNS indexes.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 6, 2023

First Posted

October 17, 2023

Study Start

April 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 10, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

It is not preferred to share the data until the study is published.

Locations

TU(1)