Vagus Nerve StimulationNCT05088135
The Effect of Auricular Vagus Nerve Stimulation on EEG and EMG Measurement in Healthy Persons
A study testing Bilateral Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM., Unilateral-Right Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. and Unilateral-Left Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. in people with Vagus Nerve Stimulation and Electromyography, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Vagus Nerve Stimulation, Electromyography, Electroencephalography
- What is being tested?
- Bilateral Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM., Unilateral-Right Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. and Unilateral-Left Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-45,
- Who do not have any chronic diseases
- Who do not have to use any medication regularly
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Being tested
- Bilateral Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM., Unilateral-Right Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM., Unilateral-Left Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral Auricular Vagus Nerve Stimulation | Experimental | Vagus nerve stimulation is applied to this group from both ears. Receives: 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. Receives: 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. Receives: Device: Unilateral-Left Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: The bioelectrical activity of the brain will be measured with the EMOTIV EPOC+ EEG device for ten minutes. (after auricular vagus nerve stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Dec 2021
- Primary completion1 Feb 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vagus Nerve StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Gelisim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah Konakoglu, Istanbul Gelisim University
- Investigators
- GÜLŞAH KONAKOĞLU, Principal investigator, Istanbul Gelisim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088135
- Sponsor's protocol ID
- gulsahkonakogluBAUPhD
- Status last verified
- May 2024
- First submitted
- 8 Oct 2021
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37528897
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Auricular Vagus Nerve Stimulation on EEG and EMG Measurement in Healthy Persons
- ClinicalTrials.gov ID
- NCT05088135
- Acronym / sponsor ID
- gulsahkonakogluBAUPhD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul Gelisim UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilateral Auricular Vagus Nerve Stimulation | Experimental | Device: Bilateral Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM.Vagus nerve stimulation is applied to this group from both ears. |
| Unilateral - Right Auricular Vagus Nerve Stimulation | Experimental | Device: Unilateral-Right Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM.In this group, vagus nerve stimulation is performed only from the right ear. |
| Unilateral - Left Auricular Vagus Nerve Stimulation | Experimental | Device: Unilateral-Left Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM.In this group, vagus nerve stimulation is performed only from the left ear. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Between the ages of 18-45,
- Who do not have any chronic diseases
- Who do not have to use any medication regularly
Key exclusion criteria (3 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Bilateral Auricular Vagus Nerve Stimulation |
| 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 - Right Auricular Vagus Nerve Stimulation |
| 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. | Device | Unilateral - Left Auricular Vagus Nerve Stimulation |
Primary outcome
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Results publication: PubMed 37528897Konakoglu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GÜLŞAH KONAKOĞLU principal investigator
Istanbul Gelisim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM., Unilateral-Right Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. and Unilateral-Left Auricular Vagus Nerve Stimulation will be performed with a device called VAGUSTIM. in people with Vagus Nerve Stimulation and Electromyography, run by Istanbul Gelisim University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05088135, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.