Clinical trial NCT05088135: The Effect of Auricular Vagus Nerve Stimulation on EEG and EMG Measurement in Healthy Persons
Official title: The Effect of Auricular Vagus Nerve Stimulation on EEG and EMG Measurement in Healthy Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vagus Nerve Stimulation
Electromyography
Electroencephalography
Lead sponsor: Istanbul Gelisim University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: 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.

Eligibility criteria: 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 .

Primary outcomes:
measure: Mean activitation value of the wrist extensor group muscles (mV) - before auricular vagus nerve stimulation
timeFrame: The measurements will be recorded during 30 sec intervals 3 times 5 sec maximum isometric hand grip-before auricular vagus nerve stimulation
measure: Maximum hand grip strenght (kg) - before auricular vagus nerve stimulation
timeFrame: The measurements will be recorded during 30 sec intervals 3 times 5 sec maximum isometric hand grip - before auricular vagus nerve stimulation
measure: Electroencephalography- Frequency bands(Hz)- before auricular vagus nerve stimulation
timeFrame: The bioelectrical activity of the brain will be measured with the EMOTIV EPOC+ EEG device for ten minutes. (before auricular vagus nerve stimulation
measure: Mean activitation value of the wrist extensor group muscles (mV) - after auricular vagus nerve stimulation
timeFrame: The measurements will be recorded during 30 sec intervals 3 times 5 sec maximum isometric hand grip - -after auricular vagus nerve stimulation
measure: Maximum hand grip strenght (kg) - after auricular vagus nerve stimulation
timeFrame: The measurements will be recorded during 30 sec intervals 3 times 5 sec maximum isometric hand grip - after auricular vagus nerve stimulation
measure: Electroencephalography- Frequency bands(Hz)- after auricular vagus nerve stimulation
timeFrame: The bioelectrical activity of the brain will be measured with the EMOTIV EPOC+ EEG device for ten minutes. (after auricular vagus nerve stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Şi̇şli̇
country: Turkey
facility: Gülşah Konakoğlu
state: İstanbul
Study officials:
affiliation: Istanbul Gelisim University
name: GÜLŞAH KONAKOĞLU
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.