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Clinical Trials/NCT06985043
NCT06985043CompletedNot Applicable

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

Bahçeşehir University1 site in 1 country30 target enrollmentStarted: May 25, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Muscle strenght

Study Overview

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

Detailed Description

The vagus nerve (VN), the tenth cranial nerve, is a key component of the neuroendocrine-immune axis and plays a critical role in regulating autonomic functions such as cardiovascular, endocrine, respiratory, and digestive system activity through its extensive central and peripheral connections (1,2). Non-invasive vagus nerve stimulation (VNS), particularly through auricular stimulation, has been shown to modulate autonomic balance by reducing sympathetic activity, enhancing cardiac baroreflex sensitivity, and improving parasympathetic tone (3,4).

In the context of athletic performance, the autonomic nervous system's role in adaptation to training and recovery is well recognized (5). Post-exercise parasympathetic reactivation is increasingly used as a biomarker for recovery and performance enhancement. Auricular VNS (aVNS), by stimulating afferent auricular branches of the VN, may facilitate recovery by reducing exercise-induced fatigue, pain, and lactate accumulation, while improving parasympathetic activity (3). Importantly, these physiological effects have been observed without significant alterations in heart rate or blood pressure.

Balance training is a known contributor to improved functional performance in athletes, and neuromuscular control is essential for injury prevention and overall athletic capacity (6). Considering the limited research on the effects of aVNS on neuromuscular parameters such as muscle strength and balance response in non-elite athletic populations, this study aims to provide evidence on the efficacy of aVNS in this context.

This study is designed as a non-randomized controlled trial. Thirty non-elite athletes aged 18-35 years, who have been physically active for at least three months and currently exercise 2-5 days per week (averaging 3.2 hours per week), will be recruited. Eligible participants must have a BMI between 18.5 and 25 kg/m² and provide informed consent. Individuals with conditions affecting the inner or outer ear or BMI values outside the specified range will be excluded.

The intervention group will receive a single session of bilateral aVNS using a biphasic, asymmetric waveform at a frequency of 25 Hz, pulse width of 300 microseconds, applied continuously for 20 minutes. The post-intervention follow-up period will last 30 minutes (3).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •have a chronic musculoskeletal disease

Arms & Interventions

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.

Intervention: Auricular vagus nerve stimulation (AVNS) (Device)

Outcomes

Primary Outcomes

Muscle strenght

Time Frame: Baseline and after the vagus stimulation apply

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

Balance

Time Frame: Baseline and after the vagus stimulation apply

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Bahçeşehir University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tuğçe Poyraz İşleyen

PT

Bahçeşehir University

Study Sites (1)

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