The Effect of Auricular Vagus Nerve Stimulation on EEG and EMG Measurement in Healthy Persons

NCT05088135 | Completed

• 1 other identifier: gulsahkonakogluBAUPhD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aimed to divide the healthy individuals aged between 18-45 years, included in our study, into three groups as bilateral, unilateral-right and unilateral-left Auricular Vagus Nerve Stimulation (VNS). The investigators planned to examine the effects of vagal nerve stimulation applied to each group with superficial EMG and EEG measurements before and after. Auricular vagus nerve stimulation has effects on cerebral activity. Therefore, this effect will be evaluated with EEG. In addition, whether there is a secondary peripheral effect will be examined by EMG method. Changes to be detected in EEG and EMG in healthy individuals may give an idea about the use of auricular vagus nerve stimulation in patients. In this study, healthy individuals between the ages of 18-45, who do not have any chronic diseases and who do not have to use any medication regularly will be included in all three groups. Due to the superficial EMG measurement method the investigators used, those who have orthopedic problems in the upper extremity (shoulder, elbow, wrist and fingers) or have a history of surgical operation in the upper extremity, however, any systemic disease such as diabetes, gout, chronic kidney failure, rheumatoid arthritis, thyroid diseases individuals will be excluded from the study in all three groups.

Conditions

Vagus Nerve Stimulation; Electromyography; Electroencephalography

Outcome Measures

Primary Outcomes (6)

• Mean activitation value of the wrist extensor group muscles (mV) - before auricular vagus nerve stimulation

  The mean extensor muscle activitation will be taken during maximum isometric contraction through extensor muscles motor point of the wrist, and dominant and non-dominant hand grip strength will be measured simultaneously with the hand dynamometer of the same device. (before auricular vagus nerve stimulation)

  The measurements will be recorded during 30 sec intervals 3 times 5 sec maximum isometric hand grip-before auricular vagus nerve stimulation

• Maximum hand grip strenght (kg) - before auricular vagus nerve stimulation

  Maximum hand grip strenght will be taken simultaneously surface EMG. (dominant and non dominant hand, before auricular vagus nerve stimulation)

  The measurements will be recorded during 30 sec intervals 3 times 5 sec maximum isometric hand grip - before auricular vagus nerve stimulation

• Electroencephalography- Frequency bands(Hz)- before auricular vagus nerve stimulation

  The bioelectrical activity of the brain will be measured with the EMOTIV EPOC+ EEG device for ten minutes. (before auricular vagus nerve stimulation)

  The bioelectrical activity of the brain will be measured with the EMOTIV EPOC+ EEG device for ten minutes. (before auricular vagus nerve stimulation

• Mean activitation value of the wrist extensor group muscles (mV) - after auricular vagus nerve stimulation

  The mean extensor muscle activitation will be taken during maximum isometric contraction through extensor muscles motor point of the wrist, and dominant and non-dominant hand grip strength will be measured simultaneously with the hand dynamometer of the same device. (after auricular vagus nerve stimulation)

  The measurements will be recorded during 30 sec intervals 3 times 5 sec maximum isometric hand grip - -after auricular vagus nerve stimulation

• Maximum hand grip strenght (kg) - after auricular vagus nerve stimulation

  Maximum hand grip strenght will be taken simultaneously surface EMG. (dominant and non dominant hand, after auricular vagus nerve stimulation)

  The measurements will be recorded during 30 sec intervals 3 times 5 sec maximum isometric hand grip - after auricular vagus nerve stimulation

• Electroencephalography- Frequency bands(Hz)- after auricular vagus nerve stimulation

  The bioelectrical activity of the brain will be measured with the EMOTIV EPOC+ EEG device for ten minutes. (after auricular vagus nerve stimulation)

  The bioelectrical activity of the brain will be measured with the EMOTIV EPOC+ EEG device for ten minutes. (after auricular vagus nerve stimulation

Study Arms (3)

Bilateral Auricular Vagus Nerve Stimulation

EXPERIMENTAL

Vagus nerve stimulation is applied to this group from both ears.

Device: Bilateral Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM.

Unilateral - Right Auricular Vagus Nerve Stimulation

EXPERIMENTAL

In this group, vagus nerve stimulation is performed only from the right ear.

Device: Unilateral-Right Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM.

Unilateral - Left Auricular Vagus Nerve Stimulation

EXPERIMENTAL

In this group, vagus nerve stimulation is performed only from the left ear.

Device: Unilateral-Left Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM.

Interventions

Bilateral Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. DEVICE

It will be divided three groups as bilateral Auricular Vagus Nerve Stimulation (VSS). Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. Auricular Vagus Nerve Stimulation will be performed for 20 minutes with a frequency of 10 Hz and a pulse width of 300 µs.

Bilateral Auricular Vagus Nerve Stimulation

Unilateral-Right Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. DEVICE

It will be divided three groups as unilateral-right Auricular Vagus Nerve Stimulation (VSS). Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. Auricular Vagus Nerve Stimulation will be performed for 20 minutes with a frequency of 10 Hz and a pulse width of 300 µs.

Unilateral - Right Auricular Vagus Nerve Stimulation

Unilateral-Left Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. DEVICE

It will be divided three groups as unilateral-left Auricular Vagus Nerve Stimulation (VSS). Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. Auricular Vagus Nerve Stimulation will be performed for 20 minutes with a frequency of 10 Hz and a pulse width of 300 µs.

Unilateral - Left Auricular Vagus Nerve Stimulation

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 18-45,
• Who do not have any chronic diseases
• Who do not have to use any medication regularly

You may not qualify if:

• Due to the superficial EMG measurement method we used,
• Those who have orthopedic problems in the upper extremity (shoulder, elbow, wrist and fingers) or have a history of surgical operation in the upper extremity,
• Systemic disease such as diabetes, gout, chronic kidney failure, rheumatoid arthritis, thyroid diseases individuals .

Sponsors & Collaborators

• Istanbul Gelisim University: lead

Study Sites (1)

Gülşah Konakoğlu

Şişli, Istanbul, 34381, Turkey (Türkiye)

Location

Related Publications (1)

• Konakoglu G, Ozden AV, Solmaz H, Bildik C. The effect of auricular vagus nerve stimulation on electroencephalography and electromyography measurements in healthy persons. Front Physiol. 2023 Jul 17;14:1215757. doi: 10.3389/fphys.2023.1215757. eCollection 2023.

  PMID: 37528897 RESULT

Study Officials

• GÜLŞAH KONAKOĞLU

  Istanbul Gelisim University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: October 21, 2021
• Study Start: December 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)