Comparison of Effectiveness In-ear and Behind-ear Vagus Nerve Stimulation

NCT06312293 | Completed DMC

• 1 other identifier: STUDYAP0004
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The use of vagus nerve stimulation (VSS), one of the examples of neuromodulation therapies, continues to increase in the medical field. Basically, invasive (iVSS) and transcutaneous VSS (tVSS) can be performed. tVSS is more preferred because of its advantages such as easy application, not requiring surgical procedure and having fewer side effects. VSS has long been an approved treatment modality in the treatment of epilepsy and refractory depression. tVSS can be administered from the auricular-auricular or posterior ear region. The vagus nerve (VS) belongs to the parasympathetic branch of the autonomic nervous system and has an effect on vital functions. There are also studies in the literature showing that VS stimulation reduces inflammation. In addition to this effect, the vagus nerve may also show analgesic activity through pain-related pathways. Due to its anti-inflammatory and analgesic effects, VSS has become a new treatment method in diseases in which various inflammatory processes are shown in the etiology such as inflammatory bowel diseases, musculoskeletal system diseases and central nervous system diseases.

Conditions

Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability

  The effectiveness of vagus nerve stimulation, its effect on autonomic nervous system activity was evaluated using heart rate variability. Polar H7 device was used for this. The heart rate was recorded non-invasively over the chest for 5 minutes and the beat-to-beat (R-R) variability was measured with Kubios software.

  Baseline and immediately after the intervention

Study Arms (4)

In-Ear stimulation

EXPERIMENTAL

Participants in this group underwent intra-ear transcutaneous vagus nerve simulation.

Device: Transcutaneous Vagus Nerve Stimulation

Behind the ear stimulation

EXPERIMENTAL

Participants in this group underwent transcutaneous vagus nerve simulation behind the ear.

Device: Transcutaneous Vagus Nerve Stimulation

In-Ear stimulation (device switched off)

PLACEBO COMPARATOR

In order to see the placebo effect of in-ear simulation in participants in this group, the electrode was placed inside the ear with the device closed and the results were evaluated.

Device: Transcutaneous Vagus Nerve Stimulation

Behind the ear stimulation (device switched off)

PLACEBO COMPARATOR

In order to see the placebo effect of behind-ear simulation in participants in this group, the electrode was placed inside the ear with the device closed and the results were evaluated.

Device: Transcutaneous Vagus Nerve Stimulation

Interventions

Transcutaneous Vagus Nerve Stimulation DEVICE

All techniques used to stimulate the vagal nerve are called vagus nerve stimulation.

Behind the ear stimulation; Behind the ear stimulation (device switched off); In-Ear stimulation; In-Ear stimulation (device switched off)

Eligibility Criteria

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

You may qualify if:

• To be 18 years of age or older,
• Not having any acute or chronic health problems,
• No previous transcutaneous vagus nerve stimulation application.

You may not qualify if:

• Using drugs, alcohol or smoking
• Being in the post menopausal phase
• Pregnancy history
• Known history of acute or chronic illness
• Having received any medication affecting the autonomic nervous system

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Igdir University

Iğdır, Central, 76000, Turkey (Türkiye)

Location

Related Publications (5)

• Szeles JC, Kampusch S, Thurk F, Clodi C, Thomas N, Fichtenbauer S, Schwanzer C, Schwarzenberger S, Neumayer C, Kaniusas E. Bursted auricular vagus nerve stimulation alters heart rate variability in healthy subjects. Physiol Meas. 2021 Oct 29;42(10). doi: 10.1088/1361-6579/ac24e6.

  PMID: 34496357 BACKGROUND

• Clancy JA, Mary DA, Witte KK, Greenwood JP, Deuchars SA, Deuchars J. Non-invasive vagus nerve stimulation in healthy humans reduces sympathetic nerve activity. Brain Stimul. 2014 Nov-Dec;7(6):871-7. doi: 10.1016/j.brs.2014.07.031. Epub 2014 Jul 16.

  PMID: 25164906 BACKGROUND

• Carandina A, Rodrigues GD, Di Francesco P, Filtz A, Bellocchi C, Furlan L, Carugo S, Montano N, Tobaldini E. Effects of transcutaneous auricular vagus nerve stimulation on cardiovascular autonomic control in health and disease. Auton Neurosci. 2021 Dec;236:102893. doi: 10.1016/j.autneu.2021.102893. Epub 2021 Oct 9.

  PMID: 34649119 BACKGROUND

• Trevizol AP, Shiozawa P, Taiar I, Soares A, Gomes JS, Barros MD, Liquidato BM, Cordeiro Q. Transcutaneous Vagus Nerve Stimulation (taVNS) for Major Depressive Disorder: An Open Label Proof-of-Concept Trial. Brain Stimul. 2016 May-Jun;9(3):453-454. doi: 10.1016/j.brs.2016.02.001. Epub 2016 Feb 10. No abstract available.

  PMID: 26944188 BACKGROUND

• Peng X, Baker-Vogel B, Sarhan M, Short EB, Zhu W, Liu H, Kautz S, Badran BW. Left or right ear? A neuroimaging study using combined taVNS/fMRI to understand the interaction between ear stimulation target and lesion location in chronic stroke. Brain Stimul. 2023 Jul-Aug;16(4):1144-1153. doi: 10.1016/j.brs.2023.07.050. Epub 2023 Jul 28.

  PMID: 37517466 BACKGROUND

Study Officials

• Ramazan Erenler, Prof. Dr.

  Igdir University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: March 15, 2024
• Study Start: September 15, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)