Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06793800

Effect of Transcutaneous Auricular Vagus Nerve Stimulation Application on Respiratory Functions in Stroke Patients

The purpose of this study is to evaluate the effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation (TAVSS) in improving respiratory muscle strength and function in chronic stroke patients. It aims to explore TAVSS as a potential complementary approach in enhancing rehabilitation outcomes for this population.

Recruiting

Interested in participating?

Request Info

Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mediworld Medical Center Physical Therapy and Rehabilitation Department

Istanbul, 34040, Turkey (Türkiye)

Location status: Recruiting

Location contact

About this study

Introduction Stroke is one of the leading causes of morbidity and long-term disability worldwide. Respiratory muscle weakness is a common complication in stroke patients, leading to respiratory dysfunction, increased aspiration risk, and higher mortality. Post-stroke, reduced vital capacity, maximum inspiratory and expiratory pressure, and low expiratory reserve volume significantly affect respiratory muscle function.

Objective This study aims to investigate the effects of Transcutaneous Auricular Vagus Nerve Stimulation (TAVSS) on respiratory parameters in chronic stroke patients.

Participants and Methods

The study included 50 chronic stroke patients in their 1st to 3rd year post-stroke, meeting specific motor levels in Brunnstrom Staging.

Participants were randomized equally into experimental (TAVSS + conventional physiotherapy) and control (sham TAVSS + conventional physiotherapy) groups.

Treatment Protocol

Experimental Group: TAVSS and conventional physiotherapy were applied three times per week for a total of 10 sessions. TAVSS was delivered for 20 minutes using a biphasic asymmetric waveform.

Control Group: Sham TAVSS (without current) and conventional physiotherapy were applied with the same frequency and duration.

Both groups received individualized physiotherapy protocols, including strengthening, stretching, balance exercises, electrotherapy, and neurodevelopmental treatment.

Measurements and Evaluation

Chest circumference measurements were taken at the axillary, epigastric, and subcostal regions during deep inspiration and expiration using a tape measure.

Respiratory function parameters (Maximum Inspiratory Pressure, Maximum Expiratory Pressure, Forced Expiratory Volume in 1 Second, Forced Vital Capacity, Forced Expiratory Volume in 1 Second to Forced Vital Capacity Ratio) were measured using the Minispir 2 spirometer before treatment and after the 10th session.

Conclusion and Recommendations The study aims to evaluate the impact of TAVSS on improving respiratory muscle strength and function, presenting an alternative approach in stroke rehabilitation. TAVSS is expected to support respiratory function and positively influence rehabilitation outcomes in stroke patients

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being a chronic stroke patient with an ischemic or hemorrhagic stroke diagnosis made 1-3 years ago
  • Having been diagnosed with stroke for the first time
  • Ability to understand and follow simple verbal instructions
  • Being between the ages of 40 and 80
  • No conditions affecting perioral muscles, such as facial paralysis or swallowing disorders
  • No visual, auditory, or communication problems
  • No cardiopulmonary disorders
  • No additional neurological, cardiovascular, orthopedic, or similar conditions causing balance problems
  • Mini Mental State Examination (MMSE) score ≥24
  • No surgical operations or Botox applications in the last 6 months
  • Scoring 2 or below on the Modified Ashworth Scale

Exclusion criteria

  • Presence of infection, ulcer, or scar on the auricle
  • Metallic implants in the skull, hypersensitivity, injury, or inflammation inside the ear
  • Chronic pulmonary and/or cardiac diseases
  • Resting heart rate below 60 beats per minute
  • Devices such as pacemakers or cochlear implants
  • Uncontrolled hypertension
  • Chronic obstructive pulmonary disease (COPD) or asthma unrelated to stroke
  • History of surgical operation or Botox application within the last 6 months
  • Presence of aphasia, apraxia, or neglect syndrome
  • History of 2 or more strokes (SVO)
  • Comorbid conditions affecting respiratory functions (e.g., Multiple Sclerosis, Parkinson's, spinal cord injury, contractures, deformities after fractures, active upper or lower respiratory infections, etc.)
  • Lack of cooperation

Treatment and study plan

Transcutaneous Auricular Vagus Nerve Stimulation

Device

TAVSS is an application system that uses an electrical transcutaneous stimulation device placed on the concha or tragus of the ear. Functional Magnetic Resonance Imaging studies have shown that stimulation of these areas activates the ipsilateral nucleus tractus solitarius (NTS) via vagal projections to the brainstem and forebrain. Unlike cervical vagus nerve stimulation, TAVSS utilizes a physiological pathway to activate the NTS and the dorsal motor nucleus, which subsequently sends impulses bilaterally to the heart surface via efferent cervical vagus nerves. Therefore, this technique eliminates the possibility of directly and asymmetrically stimulating cardiac motor efferent fibers, which could lead to adverse cardiac events. TAVSS combines advantageous qualities such as being non-invasive, cost-effective, convenient, and efficient.

Primary outcomes

  1. Inspiratory muscle strength

    Time frame: From enrollment to the end of treatment at 4 weeks

    Inspiratory muscle strength will be measured using the Minispir 2 spirometer by Medical International Research. This spirometer, classified as a Class II medical device (medium risk) by Health Canada, is a non-invasive tool for assessing respiratory function. It evaluates lung ventilation by measuring the air volume during inspiration and expiration. The device records inspiratory effort and lung capacity, helping determine respiratory muscle performance.

  2. Expiratory muscle strength

    Time frame: From enrollment to the end of treatment at 4 weeks

    Expiratory muscle strength will be measured using the Minispir 2 spirometer by Medical International Research. This spirometer, classified as a Class II medical device (medium risk) by Health Canada, is a non-invasive tool for assessing respiratory function. It evaluates lung ventilation by measuring air volume during expiration, helping assess expiratory muscle performance and overall pulmonary function.

  3. Forced Expiratory Volume in 1 Second (FEV₁)

    Time frame: From enrollment to the end of treatment at 4 weeks

    Forced Expiratory Volume in 1 Second (FEV₁) will be measured using the Minispir 2 spirometer by Medical International Research. This spirometer, classified as a Class II medical device (medium risk) by Health Canada, is a non-invasive tool for assessing respiratory function. It evaluates lung ventilation by measuring the air volume exhaled in the first second of a forced expiration, providing critical data on airway obstruction and pulmonary function.

  4. Forced Vital Capacity (FVC)

    Time frame: From enrollment to the end of treatment at 4 weeks

    Forced Vital Capacity (FVC) will be measured using the Minispir 2 spirometer by Medical International Research. This spirometer, classified as a Class II medical device (medium risk) by Health Canada, is a non-invasive tool for assessing respiratory function. It evaluates lung ventilation by measuring the maximum air volume forcefully exhaled after a deep inhalation, providing essential data on pulmonary function and lung capacity.

  5. Forced Expiratory Volume in 1 Second (FEV₁) to Forced Vital Capacity (FVC)

    Time frame: From enrollment to the end of treatment at 4 weeks

    Forced Expiratory Volume in 1 Second (FEV₁) to Forced Vital Capacity (FVC) ratio will be measured using the Minispir 2 spirometer by Medical International Research. This spirometer, classified as a Class II medical device (medium risk) by Health Canada, is a non-invasive tool for assessing respiratory function. It evaluates lung ventilation by determining the proportion of air exhaled in the first second relative to total forced vital capacity, providing key insights into airway obstruction and pulmonary function.

Secondary outcomes

  1. Chest Circumference Measurement

    Time frame: From enrollment to the end of treatment at 4 weeks

    The chest circumference of patients in the Experimental and Control groups will be measured during deep inspiration and expiration using a measuring tape. Measurements will be taken at the axillary, epigastric, and subcostal regions as both baseline (initial) and post-treatment (final) assessments.

Study contacts

Contact information is provided by the study sponsor or research team.

Burcu AKKURT, Ph.D.

CONTACT

[email protected]

+9005536046713

Mustafa AKKURT, Ph.D.

CONTACT

[email protected]

+9005055762579

Sponsors and collaborators

Lead sponsor

Fenerbahce University

Other

Registry information

Official study title

Effect of TAVNS Application on Respiratory Functions in Stroke Patients

Acronym: TAVNS

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Jan 27, 2025
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.