StrokeNCT07259577
Effects of Vagus Nerve Stimulation on Motor Function, Respiratory Muscle Strength, and Quality of Life in Stroke Patients
A study testing Robotics Assisted Education + taVNS in people with Stroke and Stroke Treatment, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Stroke is one of the leading causes of death and permanent disability worldwide. Loss of upper extremity (UE) function after stroke significantly reduces independence and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke, Stroke Treatment
- What is being tested?
- Robotics Assisted Education + taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Oct 2025to 1 Jun 2026
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18-70 years diagnosed with ischemic or hemorrhagic stroke lasting longer than 6 months,
- Moderate to severe upper extremity weakness (20-50 out of 66 on the Fugl-Meyer Upper Extremity Motor Assessment Scale),
- Ability to communicate and understand (Mini Mental State Examination (MMSE) score ≥ 23),
- Upper extremity spasticity of 2 or less on the Modified Ashworth Scale.
Who cannot join
- Use of any stimulation device, such as a pacemaker or other neurostimulator,
- Presence of a medical or cognitive condition (personality disorder, anxiety, depression, etc.) that would prevent participants from participating in the study,
- Receiving a Botox injection into the affected upper extremity at least 4 weeks prior,
- Severe spasticity in the upper extremity (Modified Ashworth Scale ≥3),
- Presence of dysphagia or aphasia,
- Presence of cardiac problems such as atrial fibrillation, atrial flutter, sick sinus syndrome, or atrioventricular block.
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
İstanbul Üniversitesi-Cerrahpaşa Sağlık Bilimleri Fakültesi Büyükçekmece Yerleşkesi
Istanbul, Istanbul
RÜSTEM MUSTAFAOĞLU, +90 555 417 8535, rustem.mustafaoglu@iuc.edu.tr
About this study
Stroke is one of the leading causes of death and permanent disability worldwide. Loss of upper extremity (UE) function after stroke significantly reduces independence and quality of life. Moreover, weakness in the respiratory muscles negatively affects trunk control and respiratory function, limiting overall functional recovery. In recent years, robot-assisted training (RAT) and non-invasive neuromodulation techniques-particularly transcutaneous auricular vagus nerve stimulation (taVNS)-have emerged as promising approaches to enhance neuroplasticity in stroke rehabilitation.
This study aims to investigate the effects of taVNS combined with robot-assisted training on upper extremity motor function, respiratory muscle strength, and quality of life in individuals with stroke.
Read more
This randomized controlled trial will be conducted in collaboration between Istanbul University-Cerrahpaşa and Istanbul Medeniyet University. Thirty individuals aged 18-70 years, with moderate-to-severe upper extremity weakness and a history of stroke of at least six months, will be included. Participants will be randomly assigned to two groups: RAT + taVNS (n=15), RAT + sham taVNS (n=15). Both groups will receive conventional rehabilitation for 45 minutes, three times per week for five weeks. Additionally, each group will undergo 45-minute sessions of RAT twice per week for five weeks, with either active or sham taVNS applied concurrently.
The primary outcome measure will be the Fugl-Meyer Upper Extremity Motor Assessment (FM-UE). Secondary outcomes will include the Stroke Impact Scale (SIS), Maximum Inspiratory Pressure (MIP), Maximum Expiratory Pressure (MEP), and Fatigue Assessment Scale (FAS). Assessments will be conducted at baseline and at the end of the fifth week.
Combining taVNS with robot-assisted upper extremity rehabilitation is expected to result in greater improvements in motor function, respiratory muscle strength, and quality of life compared to robot-assisted rehabilitation alone. This study will provide valuable insights into the synergistic effects of neuromodulation and robotic therapy in stroke rehabilitation and contribute to the growing body of evidence supporting non-invasive, technology-assisted treatment approaches.
- Conditions
- Stroke, Stroke Treatment
- Being tested
- Robotics Assisted Education + taVNS, Robotics Assisted Education + sham
- Keywords
- stroke, Upper Extremity Robot-Assisted Training, Transcutaneous Auricular Vagus Nerve Stimulation, taVNS, Respiratory Muscle Strength
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotics Assisted Education + taVNSDevice
Conventional rehabilitation will be administered 3 days a week, 45 minutes per day, for 5 weeks. The combination of Upper Extremity Robotic-Assisted Training and Transcutaneous Auricular Vagus Nerve Stimulation will be administered 2 days a week, 45 minutes per day, for 5 weeks.
Robotics Assisted Education + shamOther
Conventional rehabilitation will be administered 3 days a week, 45 minutes per day, for 5 weeks. The combination of Upper Extremity Robotic-Assisted Training and Sham Transcutaneous Auricular Vagus Nerve Stimulation will be administered 2 days a week, 45 minutes per day, for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Robotics Assisted Education + taVNS | Active comparator | Not described Receives: Device: Robotics Assisted Education + taVNS |
| Robotics Assisted Education + sham | Sham comparator | Not described Receives: Other: Robotics Assisted Education + sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Upper Extremity Evaluation (FM-UE)
We will use the Fugl-Meyer Upper Motor Assessment score, which is the most sensitive for treatment outcomes in stroke patients presenting with unilateral paresis in the post-stroke period. It measures upper extremity use and impairment, measuring shoulder, elbow, forearm, wrist, finger, and reflex movements from proximal to distal, synergistic to extrinsic. The score ranges from 0 to 66 and consists of 33 items. 0-28 indicates severe motor impairment; 29-42 indicates moderate motor impairment; and 43-66 indicates mild motor impairment. Higher scores indicate better performance. The FM-UE consists of one component, each rated on a 3-point ordinal scale (0=not achieved, 1=partially contributed, 2=completely contributed). The minimum clinically meaningful change on the FM-UE for chronic stroke has been determined to be 4.25 to 7.25. Consistent with the literature, we define an improvement of at least 6 points or more as significant.
Measured: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
Secondary outcomes (4)
Stroke Impact Scale (SIS)
The SIS 3.0 assesses function and quality of life based on subjective report in eight clinically important domains. It consists of two parts. The first part is the main scale of the IAS, which assesses multidimensional health-related quality of life (QOL) including strength, hand function, ADL/instrumental ADL, mobility, communication, emotion, memory/thinking, and social participation. It consists of 59 items, and each item is subjectively rated by stroke patients on a 5-point Likert-type scale according to their perceived difficulty with the item in the past week. The score for each domain is converted to a score out of 100, and the average scores for all domains are used to represent stroke patients' multidimensional health-related quality of life. The formula Domain Score = [(Average Item Score -1) / (5 -1) x 100] is used to convert each domain score. SIS 3.0 also includes assessment of post-stroke recovery using a 0-100 visual analog scale (0: no recovery, 100: complete recovery)
Measured: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
Maximum Inspiratory Pressure (MIP)
This is the pressure measured when the patient tries to breathe as forcefully as possible into their lungs (inspiration). It assesses the strength of the diaphragm and accessory respiratory muscles-in other words, the inspiratory capacity of the respiratory muscles. The measurement is taken through the mouth. A nose clip is applied. After maximum exhalation near the residual volume (RV), the patient tries to breathe in as forcefully as possible for 1-2 seconds. Three repetitions are performed, and the average is calculated. (The higher the pressure value, the greater the muscle strength.)
Measured: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
Maximum Expiratory Pressure (MEP)
This is the pressure measured during the patient's strongest possible exhalation (expiration). This indicates the strength of the respiratory muscles that assist exhalation, such as the abdominal muscles and internal/external intercostal muscles. The measurement is taken orally. A nose clip is applied. After taking a maximum inspiration (close to TLC), the patient attempts to exhale as forcefully as possible for 1-2 seconds. Three repetitions are performed, and the average is calculated. (The higher the pressure value, the greater the muscle strength.)
Measured: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
Fatigue Assessment Scale(FAS)
It is a brief and practical self-report instrument developed to measure the severity of fatigue experienced by individuals. It consists of 10 items, and each item is rated subjectively on a 5-point Likert-type scale used to assess overall fatigue level over the past week. The lowest score is 10, and the highest is 50. (≤ 21 points: None/low fatigue, 22-34 points: Moderate fatigue, ≥ 35 points: High fatigue)
Measured: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start6 Oct 2025
- Primary completion15 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yusuf AÇIKGÖZ, Istanbul University - Cerrahpasa
- Investigators
- Yusuf Açıkgöz, Principal investigator, Istanbul University - CerrahpasaRüstem Mustafaoğlu, Study director, Istanbul University-Cerrahpasa Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259577
- Sponsor's protocol ID
- 1439695
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vagus Nerve Stimulation on Motor Function, Respiratory Muscle Strength, and Quality of Life in Stroke Patients
- ClinicalTrials.gov ID
- NCT07259577
- Acronym / sponsor ID
- 1439695
- Conditions
- Stroke, Stroke Treatment
- Keywords
- stroke, Upper Extremity Robot-Assisted Training, Transcutaneous Auricular Vagus Nerve Stimulation, taVNS, Respiratory Muscle Strength
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 2 Dec 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.
Stroke is one of the leading causes of death and permanent disability worldwide. Loss of upper extremity (UE) function after stroke significantly reduces independence and quality of life. Moreover, weakness in the respiratory muscles negatively affects trunk control and respiratory function, limiting overall functional recovery. In recent years, robot-assisted training (RAT) and non-invasive neuromodulation techniques-particularly transcutaneous auricular vagus nerve stimulation (taVNS)-have emerged as promising approaches to enhance neuroplasticity in stroke rehabilitation.
This study aims to investigate the effects of taVNS combined with robot-assisted training on upper extremity motor function, respiratory muscle strength, and quality of life in individuals with stroke.
This randomized controlled trial will be conducted in collaboration between Istanbul University-Cerrahpaşa and Istanbul Medeniyet University. Thirty individuals aged 18-70 years, with moderate-to-severe upper extremity weakness and a history of stroke of at least six months, will be included. Participants will be randomly assigned to two groups: RAT + taVNS (n=15), RAT + sham taVNS (n=15). Both groups will receive conventional rehabilitation for 45 minutes, three times per week for five weeks. Additionally, each group will undergo 45-minute sessions of RAT twice per week for five weeks, with either active or sham taVNS applied concurrently.
The primary outcome measure will be the Fugl-Meyer Upper Extremity Motor Assessment (FM-UE). Secondary outcomes will include the Stroke Impact Scale (SIS), Maximum Inspiratory Pressure (MIP), Maximum Expiratory Pressure (MEP), and Fatigue Assessment Scale (FAS). Assessments will be conducted at baseline and at the end of the fifth week.
Combining taVNS with robot-assisted upper extremity rehabilitation is expected to result in greater improvements in motor function, respiratory muscle strength, and quality of life compared to robot-assisted rehabilitation alone. This study will provide valuable insights into the synergistic effects of neuromodulation and robotic therapy in stroke rehabilitation and contribute to the growing body of evidence supporting non-invasive, technology-assisted treatment approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotics Assisted Education + taVNS | Active comparator | Device: Robotics Assisted Education + taVNS |
| Robotics Assisted Education + sham | Sham comparator | Other: Robotics Assisted Education + sham |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged 18-70 years diagnosed with ischemic or hemorrhagic stroke lasting longer than 6 months,
- Moderate to severe upper extremity weakness (20-50 out of 66 on the Fugl-Meyer Upper Extremity Motor Assessment Scale),
- Ability to communicate and understand (Mini Mental State Examination (MMSE) score ≥ 23),
- Upper extremity spasticity of 2 or less on the Modified Ashworth Scale.
Key exclusion criteria (6 listed)
- Use of any stimulation device, such as a pacemaker or other neurostimulator,
- Presence of a medical or cognitive condition (personality disorder, anxiety, depression, etc.) that would prevent participants from participating in the study,
- Receiving a Botox injection into the affected upper extremity at least 4 weeks prior,
- Severe spasticity in the upper extremity (Modified Ashworth Scale ≥3),
- Presence of dysphagia or aphasia,
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 |
|---|---|---|
| Robotics Assisted Education + taVNSConventional rehabilitation will be administered 3 days a week, 45 minutes per day, for 5 weeks. The combination of Upper Extremity Robotic-Assisted Training and Transcutaneous Auricular Vagus Nerve Stimulation will be administered 2 days a week, 45 minutes per day, for 5 weeks. | Device | Robotics Assisted Education + taVNS |
| Robotics Assisted Education + shamConventional rehabilitation will be administered 3 days a week, 45 minutes per day, for 5 weeks. The combination of Upper Extremity Robotic-Assisted Training and Sham Transcutaneous Auricular Vagus Nerve Stimulation will be administered 2 days a week, 45 minutes per day, for 5 weeks. | Other | Robotics Assisted Education + sham |
Primary outcome
Fugl Meyer Upper Extremity Evaluation (FM-UE)
Time frame: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
We will use the Fugl-Meyer Upper Motor Assessment score, which is the most sensitive for treatment outcomes in stroke patients presenting with unilateral paresis in the post-stroke period. It measures upper extremity use and impairment, measuring shoulder, elbow, forearm, wrist, finger, and reflex movements from proximal to distal, synergistic to extrinsic. The score ranges from 0 to 66 and consists of 33 items. 0-28 indicates severe motor impairment; 29-42 indicates moderate motor impairment; and 43-66 indicates mild motor impairment. Higher scores indicate better performance. The FM-UE consists of one component, each rated on a 3-point ordinal scale (0=not achieved, 1=partially contributed, 2=completely contributed). The minimum clinically meaningful change on the FM-UE for chronic stroke has been determined to be 4.25 to 7.25. Consistent with the literature, we define an improvement of at least 6 points or more as significant.
4 secondary outcomes
Stroke Impact Scale (SIS)
Time frame: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
Maximum Inspiratory Pressure (MIP)
Time frame: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
Maximum Expiratory Pressure (MEP)
Time frame: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
Fatigue Assessment Scale(FAS)
Time frame: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
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 2 Dec 2025.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Yusuf Açıkgöz principal investigator
Istanbul University - Cerrahpasa
Rüstem Mustafaoğlu study director
Istanbul University-Cerrahpasa Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotics Assisted Education + taVNS in people with Stroke and Stroke Treatment, run by Istanbul University - Cerrahpasa 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 4 inclusion and 6 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 2 Dec 2025. 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 Yusuf Açıkgöz (+905396335531, fztysfackgz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer Upper Extremity Evaluation (FM-UE) (time frame: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).). 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 2 Dec 2025.