The Effect of Vagus Nerve Stimulation on Lower Limb Muscle Strength and Balance in Nonelite Athletes

NCT06985043 | Completed

• 1 other identifier: E-10840098-202.3.02-2218
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical Trials (Non-Randomized Controlled) The aim of this study is to evaluate whether vagus nerve stimulation can improve neuromuscular and functional outcomes in non-elite athletes aged 18-35 years living in Istanbul. The main questions it aims to answer are: Does vagus nerve stimulation improve neuromuscular performance? Does it have a positive effect on functional performance? Researchers will compare the vagus nerve stimulation group to a control group to see if the intervention leads to significant improvements in neuromuscular and functional outcomes. Participants will: Be selected based on criteria including age (18-35 years), non-elite athletic status (minimum two months), exercising 2-5 days per week for approximately 3.2 hours on average Have a Body Mass Index (BMI) between 18.5-25 kg/m² Participate voluntarily Exclusion criteria include:Any disease affecting the inner or outer ear BMI below 18.5 kg/m² or above 25 kg/m²

Conditions

Vagus Nerve Stimulations; Muscle Strength; Balance

Keywords

vagus nerve stimulations, nonelite athletes, muscle strength, balance

Outcome Measures

Primary Outcomes (2)

• Muscle strenght

  Muscle strength of quadriceps femoris and hamstring muscles will be evaluated by hand dynamometer.

  Baseline and after the vagus stimulation apply

• Balance

  Postural sway will be assessed by biodex balance with center of gravity characteristics anterior-posterior and lateral sway with eyes closed and open.

  Baseline and after the vagus stimulation apply

Study Arms (1)

Vagus nerve stimulation

EXPERIMENTAL

Auricular vagus nerve stimulation (AVNS) will be applied to both ears simultaneously, using a biphasic, asymmetric waveform with pulses of 300 microsecond duration and a frequency of 25 Hz, continuously for 20 minutes. The application will be performed in a single session and the follow-up time will be determined as 30 minutes.

Device: Auricular vagus nerve stimulation (AVNS)

Interventions

Auricular vagus nerve stimulation (AVNS) DEVICE

Auricular vagus nerve stimulation (AVNS) will be applied to both ears simultaneously, using a biphasic, asymmetric waveform with pulses of 300 microsecond duration and a frequency of 25 Hz, continuously for 20 minutes. The application will be performed in a single session and the follow-up time will be determined as 30 minutes.

Vagus nerve stimulation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• body mass index (BMI) between 18.5-25 kg/m²
• exercising for a total of 3 hours or more per week for at least three months

You may not qualify if:

• have a chronic musculoskeletal disease

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Bahcesehir university

Istanbul, Istanbul, Turkey (Türkiye)

Location

Related Publications (7)

• Peller A, Garib R, Garbe E, Komforti D, Joffe C, Magras A, Trapuzzano A, Stock MS, Dawson NT. Validity and reliability of the NIH Toolbox(R) Standing Balance Test As compared to the Biodex Balance System SD. Physiother Theory Pract. 2023 Apr;39(4):827-833. doi: 10.1080/09593985.2022.2027584. Epub 2022 Jan 23.

  PMID: 35068342 BACKGROUND

• Unver B, Bakirhan S, Karatosun V. Does a weight-training exercise programme given to patients four or more years after total knee arthroplasty improve mobility: A randomized controlled trial. Arch Gerontol Geriatr. 2016 May-Jun;64:45-50. doi: 10.1016/j.archger.2016.01.003. Epub 2016 Jan 6.

  PMID: 26952376 BACKGROUND

• Hrysomallis C. Balance ability and athletic performance. Sports Med. 2011 Mar 1;41(3):221-32. doi: 10.2165/11538560-000000000-00000.

  PMID: 21395364 BACKGROUND

• Hatik SH, Arslan M, Demirbilek O, Ozden AV. The effect of transcutaneous auricular vagus nerve stimulation on cycling ergometry and recovery in healthy young individuals. Brain Behav. 2023 Dec;13(12):e3332. doi: 10.1002/brb3.3332. Epub 2023 Nov 16.

  PMID: 37974551 BACKGROUND

• Caliota A, Ozden AV, Ceylan I. Effects of a single session of noninvasive auricular vagus nerve stimulation on sports performance in elite athletes: an open-label randomized controlled trial. Expert Rev Med Devices. 2024 Mar;21(3):231-237. doi: 10.1080/17434440.2023.2299300. Epub 2023 Dec 30.

  PMID: 38146234 BACKGROUND

• Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part I. Headache. 2016 Jan;56(1):71-8. doi: 10.1111/head.12647. Epub 2015 Sep 14.

  PMID: 26364692 BACKGROUND

• Prescott SL, Liberles SD. Internal senses of the vagus nerve. Neuron. 2022 Feb 16;110(4):579-599. doi: 10.1016/j.neuron.2021.12.020. Epub 2022 Jan 19.

  PMID: 35051375 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: May 22, 2025
• Study Start: May 25, 2025
• Primary Completion: July 25, 2025
• Study Completion: July 25, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Locations

TU (1)