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

NCT05088135 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-05-14

No results posted yet for this study

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

Interventions

DEVICE

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

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.

DEVICE

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

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.

DEVICE

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

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.

Sponsors & Collaborators

  • Istanbul Gelisim University

    lead OTHER

Principal Investigators

  • GÜLŞAH KONAKOĞLU · Istanbul Gelisim University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-02-01
Completion
2022-04-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05088135 on ClinicalTrials.gov