Actively Recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Upper Extremity Robot-Assisted Training on Upper Extremity Motor Functions in Stroke Patients
Led by Istanbul University - Cerrahpasa · Updated on 2025-12-02
30
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Effect of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Upper Extremity Robot-Assisted Training on Upper Extremity Motor Functions in Stroke Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years
- Diagnosed with ischemic or hemorrhagic stroke lasting more than 6 months
- Moderate to severe upper extremity weakness (Fugl-Meyer Upper Extremity Motor Assessment score 20-50 out of 66)
- Ability to communicate and understand (Mini Mental State Examination score 23)
- Upper extremity spasticity of 2 or less on the Modified Ashworth Scale
You will not qualify if you...
- Use of any stimulation device such as a pacemaker or other neurostimulator
- Medical or cognitive conditions (e.g., personality disorder, anxiety, depression) preventing study participation
- Received Botox injection in affected upper extremity within the last 4 weeks
- Severe upper extremity spasticity (Modified Ashworth Scale 3 or higher)
- Presence of dysphagia or aphasia
- Cardiac problems such as atrial fibrillation, atrial flutter, sick sinus syndrome, or atrioventricular block
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
İstanbul Üniversitesi-Cerrahpaşa Sağlık Bilimleri Fakültesi Büyükçekmece Yerleşkesi
Istanbul, Istanbul, Turkey (Türkiye)
Actively Recruiting
Research Team
R
Rüstem MUSTAFAOĞLU, associate professor
CONTACT
Y
Yusuf Açıkgöz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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