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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
NA trial testing Robotics Assisted Education + taVNS in Stroke Treatment in 30 participants. Currently enrolling.
1 March 2027
Quick facts
| Lead sponsor | Istanbul University - Cerrahpasa |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 October 2025 |
| Primary completion | 1 March 2027 |
| Estimated completion | 1 June 2027 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Robotics Assisted Education + taVNS
- Robotics Assisted Education + sham
Conditions studied
- Stroke Treatment — all drugs for Stroke Treatment →
- Stroke — all drugs for Stroke →
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.
Verify or expand the search:
- PubMed search for NCT07257107
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Related trials
Other trials of Robotics Assisted Education + taVNS
Trials testing the same drug.
- NCT07259577 — Effects of Vagus Nerve Stimulation on Motor Function, Respiratory Muscle Strength, and Quality of Life in Stroke Patient · NA · recruiting
Other recruiting trials for Stroke Treatment
Currently open trials in the same condition.
- NCT07259577 — Effects of Vagus Nerve Stimulation on Motor Function, Respiratory Muscle Strength, and Quality of Life in Stroke Patient · NA · recruiting
- NCT06332989 — Stroke Triage Optimization by Ambulance Paramedics in the Pre-hospital Setting · recruiting
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07257107 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istanbul University - Cerrahpasa
- Last refreshed: 2 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07257107.
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