Actively Recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Respiratory Functions in Stroke Patients
Led by Fenerbahce University · Updated on 2026-04-01
50
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of Transcutaneous Auricular Vagus Nerve Stimulation (TAVSS) on respiratory muscle strength and function in patients who have had a stroke between one and three years ago. The study focuses on chronic stroke patients who experience respiratory muscle weakness, which can lead to complications such as respiratory dysfunction, increased risk of aspiration, and higher mortality. The goal is to explore TAVSS as a potential complementary treatment to improve rehabilitation outcomes in this population. The study involves 50 participants randomized into two groups: one receiving TAVSS combined with conventional physiotherapy and the other receiving sham TAVSS with conventional physiotherapy. TAVSS is applied using electrodes placed on specific parts of the outer ear, delivering electrical stimulation continuously for 20 minutes per session, three times a week, for a total of 10 sessions. Both groups also receive individualized physiotherapy including strengthening, stretching, balance exercises, electrotherapy, and neurodevelopmental treatments. Participants will undergo assessments before and after the treatment period, including measurements of chest circumference during deep breathing and respiratory function tests such as maximum inspiratory and expiratory pressure, forced expiratory volume in one second (FEV1), and forced vital capacity (FVC). The primary outcomes focus on changes in respiratory muscle strength and lung function over the four-week treatment period. The study also monitors safety and tolerance of the treatments throughout the participation time.
CONDITIONS
Brief Title
Effect of Transcutaneous Auricular Vagus Nerve Stimulation Application on Respiratory Functions in Stroke Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic stroke patient diagnosed with ischemic or hemorrhagic stroke 1 to 3 years ago
- First-time stroke diagnosis
- Ability to understand and follow simple verbal instructions
- Age between 40 and 80 years
- 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 of 24 or higher
- No surgical operations or Botox treatments in the last 6 months
- Modified Ashworth Scale score of 2 or below
You will not qualify if you...
- Infection, ulcer, or scar on the auricle (outer ear)
- Metallic implants in the skull
- Hypersensitivity, injury, or inflammation inside the ear
- Chronic pulmonary or cardiac diseases
- Resting heart rate below 60 beats per minute
- Presence of 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 two or more strokes
- Comorbid conditions affecting respiratory functions such as Multiple Sclerosis, Parkinson's disease, spinal cord injury, contractures, fractures, or active respiratory infections
- Lack of cooperation or inability to participate fully
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 weeks
Participants receive either Transcutaneous Auricular Vagus Nerve Stimulation (TAVSS) combined with conventional physiotherapy or sham TAVSS combined with conventional physiotherapy. Both interventions are applied three times per week for a total of 10 sessions, each session lasting approximately 65 minutes including 20 minutes of stimulation and 45 minutes of physiotherapy.
3 visits per week for 4 weeks (total of 10 sessions)
Trial Site Locations
Total: 1 location
1
Mediworld Medical Center Physical Therapy and Rehabilitation Department
Istanbul, Turkey (Türkiye), 34040
Actively Recruiting
Research Team
B
Burcu AKKURT, Ph.D.
M
Mustafa AKKURT, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here