Stroke TreatmentNCT07257107
Effect of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Upper Extremity Robot-Assisted Training on Upper Extremity Motor Functions in Stroke Patients
A study testing Robotics Assisted Education + taVNS in people with Stroke Treatment and Stroke, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The effects of stroke on the upper extremity are a common and significant cause of long-term disability, with 65% of patients reporting an inability to participate in daily activities with the affected upper extremity after 6 months. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke Treatment, Stroke
- 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
- 1 Oct 2025to 1 Jun 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) 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), and 4) 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
The effects of stroke on the upper extremity are a common and significant cause of long-term disability, with 65% of patients reporting an inability to participate in daily activities with the affected upper extremity after 6 months. Robotic-assisted training (RAT) has been widely used in recent years to improve upper extremity function. RAT positively impacts upper extremity function and activities of daily living by inducing motor learning from intense, highly repetitive, and task-focused movements of the upper extremity. However, current, limited clinical solutions, including minimally invasive transcutaneous auricular vagus nerve stimulation (taVNS), have not yielded promising results. Therefore, the aim of this study was to investigate the effects of the combination of taVNS and RTA on motor impairment, upper extremity motor function, grip strength, daily living characteristics, and quality of life in individuals with stroke. Stroke medications were randomly assigned to RDE+taVNS (n=15) and RDE+sham taVNS (n=15). All participants will receive conventional treatment for 45 minutes per day, 3 days per week, for 5 weeks. One group will also receive RDE+taVNS treatment for 45 minutes per day, 2 days per week, for 5 weeks, while the other group will receive RDE+sha taVNS. Participants will be assessed using the Fugl-Meyer Upper Extremity Assessment, ARAT (Action Research Arm Test), and Box and Block Test as primary outcomes at baseline and after 5 weeks.
This project will contribute to the literature by demonstrating the effectiveness of taVNS, one of the most promising methods available. Furthermore, the results will prompt discussion on the applicability of the method not only to stroke patients but also to other disease groups. The unique value of this project is that it is the first study to investigate product improvements in taVNS systems.
- Conditions
- Stroke Treatment, Stroke
- Being tested
- Robotics Assisted Education + taVNS, Robotics Assisted Education + sham
- Keywords
- Stroke, Upper Extremity Robot-Assisted Training, Transcutaneous Auricular Vagus Nerve Stimulation, taVNS
- 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).
Box and Block Test (BBT)
The Box and Block Test is a manual dexterity test used to assess upper extremity motor function. It primarily assesses gross motor function. It is calculated by the number of 2.5 cm3 blocks thrown from one side to the other in 1 minute. A box and block test kit has been prepared to meet international standards.
Measured: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
Secondary outcomes (2)
Hand Grip Strength
Grip strength on the affected side will be measured with a Jamar Hydraulic Dynamometer. The measurement protocol will be explained and demonstrated to the participant by an experienced physiotherapist. The dynamometer grip size will be adjusted to the participant's hand size, and the participant will be asked to squeeze the dynamometer for a practice trial. Anti-gravity support will be provided to maintain the position if necessary. Grip strength measurements with the Jamar dynamometer have proven to be highly valid and reliable, and normative values have been published.
Measured: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
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).
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 start1 Oct 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke TreatmentStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rustem mustafaoglu, Istanbul University - Cerrahpasa
- Investigators
- Rüstem Mustafaoğlu, associate professor, Principal investigator, Istanbul University-Cerrahpasa Faculty of Health Sciences, Department of Physiotherapy and RehabilitationFatih Aykut Çavdar, Study chair, Marmara University, Faculty of Health Sciences, Department of Physiotherapy and RehabilitationYusuf Açıkgöz, Study chair, Istanbul University-Cerrahpasa, Institute of Postgraduate Educationİpek Yeldan, Professor, Study chair, Istanbul University-Cerrahpasa Faculty of Health Sciences, Department of Physiotherapy and RehabilitationBelgin Erhan, Professor, Study director, Istanbul Medeniyet University Faculty of Medicine, Department of International Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257107
- Sponsor's protocol ID
- 1277364
- Status last verified
- Sep 2025
- First submitted
- 21 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
- Effect of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Upper Extremity Robot-Assisted Training on Upper Extremity Motor Functions in Stroke Patients
- ClinicalTrials.gov ID
- NCT07257107
- Acronym / sponsor ID
- 1277364
- Conditions
- Stroke Treatment, Stroke
- Keywords
- Stroke, Upper Extremity Robot-Assisted Training, Transcutaneous Auricular Vagus Nerve Stimulation, taVNS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (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.
The effects of stroke on the upper extremity are a common and significant cause of long-term disability, with 65% of patients reporting an inability to participate in daily activities with the affected upper extremity after 6 months. Robotic-assisted training (RAT) has been widely used in recent years to improve upper extremity function. RAT positively impacts upper extremity function and activities of daily living by inducing motor learning from intense, highly repetitive, and task-focused movements of the upper extremity. However, current, limited clinical solutions, including minimally invasive transcutaneous auricular vagus nerve stimulation (taVNS), have not yielded promising results. Therefore, the aim of this study was to investigate the effects of the combination of taVNS and RTA on motor impairment, upper extremity motor function, grip strength, daily living characteristics, and quality of life in individuals with stroke. Stroke medications were randomly assigned to RDE+taVNS (n=15) and RDE+sham taVNS (n=15). All participants will receive conventional treatment for 45 minutes per day, 3 days per week, for 5 weeks. One group will also receive RDE+taVNS treatment for 45 minutes per day, 2 days per week, for 5 weeks, while the other group will receive RDE+sha taVNS. Participants will be assessed using the Fugl-Meyer Upper Extremity Assessment, ARAT (Action Research Arm Test), and Box and Block Test as primary outcomes at baseline and after 5 weeks.
This project will contribute to the literature by demonstrating the effectiveness of taVNS, one of the most promising methods available. Furthermore, the results will prompt discussion on the applicability of the method not only to stroke patients but also to other disease groups. The unique value of this project is that it is the first study to investigate product improvements in taVNS systems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- 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 (3 listed)
- 1) 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), and 4) 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.
Box and Block Test (BBT)
Time frame: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
The Box and Block Test is a manual dexterity test used to assess upper extremity motor function. It primarily assesses gross motor function. It is calculated by the number of 2.5 cm3 blocks thrown from one side to the other in 1 minute. A box and block test kit has been prepared to meet international standards.
2 secondary outcomes
Hand Grip Strength
Time frame: Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).
Stroke Impact Scale (SIS)
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.
- Individual participant dataSharing planned: No
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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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Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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Biomarkers of Paired VNS
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Not yet recruitingObservational study
The GEIR (Grupo español de Ictus Retina) Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
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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.
Rüstem Mustafaoğlu, associate professor principal investigator
Istanbul University-Cerrahpasa Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Fatih Aykut Çavdar study chair
Marmara University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
Yusuf Açıkgöz study chair
Istanbul University-Cerrahpasa, Institute of Postgraduate Education
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 Treatment and Stroke, 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 3 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 Rüstem MUSTAFAOĞLU, associate professor (+905554178535, rustem.mustafaoglu@iuc.edu.tr), 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).). The study lists 2 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 2 Dec 2025.