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

NCT07257107 | Recruiting

• 1 other identifier: 1277364
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stroke; Upper Extremity Robot-Assisted Training; Transcutaneous Auricular Vagus Nerve Stimulation; taVNS

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).

Secondary Outcomes (2)

• Hand Grip Strength

  Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).

• Stroke Impact Scale (SIS)

  Outcome measures will be assessed and recorded at baseline (assessment session) and after intervention (week 5).

Study Arms (2)

Robotics Assisted Education + taVNS

ACTIVE COMPARATOR

Device: Robotics Assisted Education + taVNS

Robotics Assisted Education + sham

SHAM COMPARATOR

Other: Robotics Assisted Education + sham

Interventions

Robotics Assisted Education + taVNS DEVICE

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 + taVNS

Robotics Assisted Education + sham OTHER

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.

Robotics Assisted Education + sham

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

İstanbul Üniversitesi-Cerrahpaşa Sağlık Bilimleri Fakültesi Büyükçekmece Yerleşkesi

Istanbul, Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rüstem Mustafaoğlu, associate professor

  Istanbul University-Cerrahpasa Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Fatih Aykut Çavdar

  Marmara University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

  STUDY CHAIR

• Yusuf Açıkgöz

  Istanbul University-Cerrahpasa, Institute of Postgraduate Education

  STUDY CHAIR

• İpek Yeldan, Professor

  Istanbul University-Cerrahpasa Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

  STUDY CHAIR

• Belgin Erhan, Professor

  Istanbul Medeniyet University Faculty of Medicine, Department of International Medicine and Rehabilitation

  STUDY DIRECTOR

Central Study Contacts

Rüstem MUSTAFAOĞLU, associate professor

CONTACT

+905554178535; rustem.mustafaoglu@iuc.edu.tr

Yusuf Açıkgöz

CONTACT

+905396335531; fztysfackgz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)