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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bahçeşehir University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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