RecruitingNot ApplicableNCT06793800

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

Effect of TAVNS Application on Respiratory Functions in Stroke Patients


Sponsor

Fenerbahce University

Enrollment

50 participants

Start Date

Aug 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria11

  • 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 Criteria12

  • 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

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Interventions

DEVICETranscutaneous Auricular Vagus Nerve Stimulation

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.


Locations(1)

Mediworld Medical Center Physical Therapy and Rehabilitation Department

Istanbul, Turkey (Türkiye)

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NCT06793800


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