Comparison of Effectiveness In-ear and Behind-ear Vagus Nerve Stimulation

March 13, 2024 updated by: Alper Percin, Bahçeşehir University

Transcutaneous Auricular Vagus Nerve Stimulation: Comparison of Effectiveness of In-ear and Behınd-ear Stimulation

The use of vagus nerve stimulation (VSS), one of the examples of neuromodulation therapies, continues to increase in the medical field. Basically, invasive (iVSS) and transcutaneous VSS (tVSS) can be performed. tVSS is more preferred because of its advantages such as easy application, not requiring surgical procedure and having fewer side effects. VSS has long been an approved treatment modality in the treatment of epilepsy and refractory depression. tVSS can be administered from the auricular-auricular or posterior ear region. The vagus nerve (VS) belongs to the parasympathetic branch of the autonomic nervous system and has an effect on vital functions. There are also studies in the literature showing that VS stimulation reduces inflammation. In addition to this effect, the vagus nerve may also show analgesic activity through pain-related pathways. Due to its anti-inflammatory and analgesic effects, VSS has become a new treatment method in diseases in which various inflammatory processes are shown in the etiology such as inflammatory bowel diseases, musculoskeletal system diseases and central nervous system diseases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There are no generally accepted values for taVNS (transcutaneous auricular vagus nerve stimulation) application parameters (amplitude, frequency, intensity, duration, side); therefore, there are heterogeneous applications in studies. In a meta-analysis on the safety profile of taVSS, local skin irritation (18. 2%), headache (3.6%), nasopharyngitis (1.7%), dizziness (1.4%) and nausea (1.1%) were reported and taVSS treatment was reported as an effective and safe treatment with these side effects, most of which were transient and did not require additional intervention.

During taVNS, autonomic activities increase in favour of the parasympathetic system and this results in an increase in heart rate variability (HRV). Although an increase in HRV has been demonstrated by different studies, the factors that can predict the change in HRV are not clear. In a study by Geng et al. using taVSS, it was observed that HRV indicators representing vagal nerve activity increased significantly when stimulation was performed in the morning, but evening stimulation did not yield similar results. In addition, they found that improvements in measures of autonomic balance were more pronounced in the presence of lower vagal activity; they also found that by increasing the duration of stimulation, the effect of taVNS on HRV was not regulated by duration. In other words, HRV changes had the best effect only at the beginning of stimulation.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Central
      • Igdir, Central, Turkey, 76000
        • Igdir University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • To be 18 years of age or older,
  • Not having any acute or chronic health problems,
  • No previous transcutaneous vagus nerve stimulation application.

Exclusion Criteria:

  • Using drugs, alcohol or smoking
  • Being in the post menopausal phase
  • Pregnancy history
  • Known history of acute or chronic illness
  • Having received any medication affecting the autonomic nervous system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: In-Ear stimulation
Participants in this group underwent intra-ear transcutaneous vagus nerve simulation.
Device: Transcutaneous Vagus Nerve Stimulation
All techniques used to stimulate the vagal nerve are called vagus nerve stimulation.
Experimental: Behind the ear stimulation
Participants in this group underwent transcutaneous vagus nerve simulation behind the ear.
Device: Transcutaneous Vagus Nerve Stimulation
All techniques used to stimulate the vagal nerve are called vagus nerve stimulation.
Placebo Comparator: In-Ear stimulation (device switched off)
In order to see the placebo effect of in-ear simulation in participants in this group, the electrode was placed inside the ear with the device closed and the results were evaluated.
Device: Transcutaneous Vagus Nerve Stimulation
All techniques used to stimulate the vagal nerve are called vagus nerve stimulation.
Placebo Comparator: Behind the ear stimulation (device switched off)
In order to see the placebo effect of behind-ear simulation in participants in this group, the electrode was placed inside the ear with the device closed and the results were evaluated.
Device: Transcutaneous Vagus Nerve Stimulation
All techniques used to stimulate the vagal nerve are called vagus nerve stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: Baseline and immediately after the intervention
The effectiveness of vagus nerve stimulation, its effect on autonomic nervous system activity was evaluated using heart rate variability. Polar H7 device was used for this. The heart rate was recorded non-invasively over the chest for 5 minutes and the beat-to-beat (R-R) variability was measured with Kubios software.
Baseline and immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bahçeşehir University

Investigators

  • Study Chair: Ramazan Erenler, Prof. Dr., Igdir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • STUDYAP0004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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