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Completed

NCT Number: NCT05088135

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

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.

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Key information

Conditions

Vagus Nerve Stimulation Electroencephalography Electromyography

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gülşah Konakoğlu

Şişli, Istanbul, 34381, Turkey (Türkiye)

About this study

Superficial EMG measurement will be made with BIOPAC EMG (Biopac systems, Santa Barbara, CA, USA). Dominant and non-dominant wrist extensor muscle electromyography will be performed with the BIOPAC (Biopac Systems, Santa Barbara, CA, USA) electromyography device and hand grip strength wiil be measured simultaneously with the hand dynamometer of the same device.

A single channel will be used for electromyography measurement , which was taken via surface electrodes (Ag-Cl) over the extensor wrist muscle; the ulnar styloid process will be selected for the ground electrode. Electrodes on the muscle will be placed about 0.5 cm apart. The measurement will be taken in the standard measurement position of the hand dynamometer, with 0° shoulder flexion, 0° shoulder abduction, 90° elbow flexion and forearm in the midline position, in the sitting position, during for 5 seconds of maximum grip.The measurement will be repeated 3 times and root mean square (RMS) calculations will be made with the MATLAB software.

The bioelectrical activity of the brain will be measured with the EMOTIV EPOC+ EEG device.

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.

The investigators are planning to examine the effects of vagal nerve stimulation, which the investigators will apply to each group using different methods, by examining the effects of vagal nerve stimulation before and after the superficial EMG and EEG measurements as well as the first test and post test measurement in each group, and at the same time, the investigators are planning to evaluate the results the investigators obtained by comparing the results between the groups in all three groups.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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 .

Treatment and study plan

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.

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-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.

Primary outcomes

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

    Time frame: The measurements will be recorded during 30 sec intervals 3 times 5 sec maximum isometric hand grip-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)

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

    Time frame: 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 will be taken simultaneously surface EMG. (dominant and non dominant hand, before auricular vagus nerve stimulation)

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

    Time frame: 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)

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

    Time frame: The measurements will be recorded during 30 sec intervals 3 times 5 sec maximum isometric hand grip - -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)

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

    Time frame: 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 will be taken simultaneously surface EMG. (dominant and non dominant hand, after auricular vagus nerve stimulation)

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Istanbul Gelisim University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2021
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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