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

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. 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

Interventions

DEVICE

Robotics Assisted Education + taVNS

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.

OTHER

Robotics Assisted Education + sham

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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa

  lead OTHER

Principal Investigators

• Rüstem Mustafaoğlu, associate professor · Istanbul University-Cerrahpasa Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

• Fatih Aykut Çavdar · Marmara University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

• Yusuf Açıkgöz · Istanbul University-Cerrahpasa, Institute of Postgraduate Education

• İpek Yeldan, Professor · Istanbul University-Cerrahpasa Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

• Belgin Erhan, Professor · Istanbul Medeniyet University Faculty of Medicine, Department of International Medicine and Rehabilitation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-01

Primary Completion

2027-03-01

Completion

2027-06-01

Countries

• Turkey (Türkiye)

Study Locations