HemiplegiaTAVNSNCT06793800
Effect of Transcutaneous Auricular Vagus Nerve Stimulation Application on Respiratory Functions in Stroke Patients
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Hemiplegia and Respiratory Function Loss, run by Fenerbahce University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Hemiplegia, Respiratory Function Loss
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Aug 2025to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mediworld Medical Center Physical Therapy and Rehabilitation Department
Istanbul, 34040
Okan, MD., +9005548607466, m.okanozturk@gmail.com
About this study
Official title: Effect of TAVNS 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.
Read the detailed description
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
- Conditions
- Hemiplegia, Respiratory Function Loss
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation
- Keywords
- hemiplegia, Vagus Nerve Stimulation, Respiration
- Medical subject headings
- Hemiplegia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental (TAVSS + conventional physiotherapy) | Experimental | TAVSS and conventional physiotherapy will be applied for a total of 10 sessions, three times a week. TAVSS application electrodes will be placed on the tragus and the inner and posterior surfaces of the concha in both the right and left outer ear. The stimulation will be delivered continuously for 20 minutes with a biphasic asymmetric waveform, a pulse duration of 300 microseconds, and a frequency of 25 hertz. Electrical stimulation will be increased in 0.1 mA increments until the perception threshold is reached. Individualized conventional physiotherapy protocols tailored to the specific needs of the patients in the experimental group will be administered by a physiotherapist for a total of 10 sessions, three times a week. The conventional physiotherapy interventions will generally include strengthening exercises, stretching exercises, proprioceptive neuromuscular facilitation, electrotherapy, balance exercises, fine motor exercises, active range of motion exercises (45 minutes). Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| control (sham TAVSS + conventional physiotherapy) | Sham comparator | shamTAVSS and conventional physiotherapy will be applied for a total of 10 sessions, three times a week. TAVSS application electrodes will be placed on the tragus and the inner and posterior surfaces of the concha in both the right and left outer ear without any current. Individualized conventional physiotherapy protocols tailored to the specific needs of the patients in this group will be administered by a physiotherapist for a total of 10 sessions, three times a week. The conventional physiotherapy interventions will generally include strengthening exercises, stretching exercises, proprioceptive neuromuscular facilitation, electrotherapy, balance exercises, fine motor exercises, active range of motion exercises (45 minutes). Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 4 weeks
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.
Measured: From enrollment to the end of treatment at 4 weeks
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.
Measured: From enrollment to the end of treatment at 4 weeks
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.
Measured: From enrollment to the end of treatment at 4 weeks
Forced Expiratory Volume in 1 Second (FEV₁) to Forced Vital Capacity (FVC)
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.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary 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.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start5 Aug 2025
- Primary completion26 Aug 2025
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by Fenerbahce UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups with experimental group (TAVSS + conventional physiotherapy) and sham TAVSS + (conventional physiotherapy)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fenerbahce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu AKKURT, Fenerbahce University
- Investigators
- Burcu AKKURT, Study director, Fenerbahce University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793800
- Sponsor's protocol ID
- 80.2024fbu
- Acronym
- TAVNS
- Status last verified
- Mar 2026
- First submitted
- 21 Jan 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of TAVNS Application on Respiratory Functions in Stroke Patients
- ClinicalTrials.gov ID
- NCT06793800
- Acronym / sponsor ID
- TAVNS / 80.2024fbu
- Conditions
- Hemiplegia, Respiratory Function Loss
- Keywords
- hemiplegia, Vagus Nerve Stimulation, Respiration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fenerbahce UniversityUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups with experimental group (TAVSS + conventional physiotherapy) and sham TAVSS + (conventional physiotherapy)
| Arm | Type | Receives |
|---|---|---|
| experimental (TAVSS + conventional physiotherapy) | Experimental | Device: Transcutaneous Auricular Vagus Nerve StimulationTAVSS and conventional physiotherapy will be applied for a total of 10 sessions, three times a week. TAVSS application electrodes will be placed on the tragus and the inner and posterior surfaces of the concha in both the right and left outer ear. The stimulation will be delivered continuously for 20 minutes with a biphasic asymmetric waveform, a pulse duration of 300 microseconds, and a frequency of 25 hertz. Electrical stimulation will be increased in 0.1 mA increments until the perception threshold is reached. Individualized conventional physiotherapy protocols tailored to the specific needs of the patients in the experimental group will be administered by a physiotherapist for a total of 10 sessions, three times a week. The conventional physiotherapy interventions will generally include strengthening exercises, stretching exercises, proprioceptive neuromuscular facilitation, electrotherapy, balance exercises, fine motor exercises, active range of motion exercises (45 minutes). |
| control (sham TAVSS + conventional physiotherapy) | Sham comparator | Device: Transcutaneous Auricular Vagus Nerve StimulationshamTAVSS and conventional physiotherapy will be applied for a total of 10 sessions, three times a week. TAVSS application electrodes will be placed on the tragus and the inner and posterior surfaces of the concha in both the right and left outer ear without any current. Individualized conventional physiotherapy protocols tailored to the specific needs of the patients in this group will be administered by a physiotherapist for a total of 10 sessions, three times a week. The conventional physiotherapy interventions will generally include strengthening exercises, stretching exercises, proprioceptive neuromuscular facilitation, electrotherapy, balance exercises, fine motor exercises, active range of motion exercises (45 minutes). |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve StimulationTAVSS 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. | Device | control (sham TAVSS + conventional physiotherapy), experimental (TAVSS + conventional physiotherapy) |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
Chest Circumference Measurement
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Burcu AKKURT study director
Fenerbahce University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Hemiplegia and Respiratory Function Loss, run by Fenerbahce University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burcu AKKURT, Ph.D. (+9005536046713, burcu.akkurt@fbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory muscle strength (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.