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NCT07257107

Effect of Transcutaneous Auricular Vagus Nerve Stimulation Combined With Upper Extremity Robot-Assisted Training on Upper Extremity Motor Functions in Stroke Patients

Recruiting now NA Last updated 2 December 2025
What this trial tests

NA trial testing Robotics Assisted Education + taVNS in Stroke Treatment in 30 participants. Currently enrolling.

Timeline
1 October 2025
Primary endpoint
1 March 2027
1 June 2027

Quick facts

Lead sponsorIstanbul University - Cerrahpasa
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment30
Start date1 October 2025
Primary completion1 March 2027
Estimated completion1 June 2027
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Istanbul University - Cerrahpasa

Who can join

Adults 18 to 70, any sex, with Stroke Treatment or Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of Robotics Assisted Education + taVNS

Trials testing the same drug.

Other recruiting trials for Stroke Treatment

Currently open trials in the same condition.

Other Istanbul University - Cerrahpasa trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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