Effect of Transcutaneous Auricular Vagus Nerve Stimulation Application on Respiratory Functions in Stroke Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorFenerbahce University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Transcutaneous Auricular Vagus Nerve Stimulation
DeviceTAVSS 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: experimental (TAVSS + conventional physiotherapy)Experimental treatment 1 intervention
Group B: control (sham TAVSS + conventional physiotherapy)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Inspiratory muscle strength
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.
Time frame
From enrollment to the end of treatment at 4 weeks2
Expiratory muscle strength
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.
Time frame
From enrollment to the end of treatment at 4 weeks3
Forced Expiratory Volume in 1 Second (FEV₁)
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.
Time frame
From enrollment to the end of treatment at 4 weeks4
Forced Vital Capacity (FVC)
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.
Time frame
From enrollment to the end of treatment at 4 weeksSecondary outcomes
1
Chest Circumference Measurement
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.
Time frame
From enrollment to the end of treatment at 4 weeksSponsors and contacts
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Source ClinicalTrials.gov