taVNS Combined With TENS on Motor Function in Stroke

NCT07425756 | Recruiting

• 1 other identifier: 25-VNS-GRF-LJ
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

the current study is a Blinded Randomised Controlled Trial investing the effectiveness of Combining Transcutaneous Vagus Nerve Stimulation with Peripheral Nerve Stimulation on Upper Limb Motor Function in People with Stroke

Conditions

Stroke

Keywords

stroke

Outcome Measures

Primary Outcomes (2)

• Fugl-Meyer assessment of upper extremity (FMA-UE)

  The FMA-UE was used to assess motor impairment. It includes 33 items assessing movement, coordination, and reflex actions of the shoulder, elbow, forearm, wrist, and hand joints of the paretic arm. Each item consists of a 3-point scale (0, 1, and 2), with a total maximum score of 66.

  Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).

• Chinese version of brief memory and executive test (BMET)

  The Chinese version of BMET will be used to assess cognitive function. It incorporates tests divided into two main categories: i) executive functioning and processing speed; and ii) orientation and memory. The initial performance of each item is converted to item score (0-2) and the total score (0-16) was used for statistical analysis, where a higher score indicates better general cognitive function.

  Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).

Secondary Outcomes (8)

• Jacket test

  Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).

• Motor Activity Log (MAL)

  Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).

• Capabilities of upper extremity test (CUE-T)

  Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).

• Hand grip strength

  Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).

• Pinch grip strength

  Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).

Study Arms (4)

taVNS + TENS

EXPERIMENTAL

participate will received taVNS cominged with TENS

Device: transcutaneous auricular vagus nerve stimulation; Device: transcutaneous electrical nerve stimulation; Other: task-oriented training

sham-taVNS + TENS

SHAM COMPARATOR

participate will received sham-taVNS cominged with TENS

Device: sham transcutaneous auricular vagus nerve stimulation; Device: transcutaneous electrical nerve stimulation; Other: task-oriented training

taVNS + sham-TENS

SHAM COMPARATOR

participate will received taVNS cominged with sham-TENS

Device: transcutaneous auricular vagus nerve stimulation; Device: sham transcutaneous electrical nerve stimulation; Other: task-oriented training

control training group

ACTIVE COMPARATOR

participate will receive exercise training only

Other: task-oriented training

Interventions

transcutaneous auricular vagus nerve stimulation DEVICE

The left cymba conchae was selected as taVNS stimulation side. The taVNS was delivered by earphone-shaped stimulators for 30 minutes with the stimulation parameters as follows: 0.3-ms square pulses at 20 Hz for 30 seconds with a duty cycle of 1:1; and the intensity of the stimulation was individually adjusted according to the tolerance of participants

taVNS + TENS; taVNS + sham-TENS

sham transcutaneous auricular vagus nerve stimulation DEVICE

The sham stimulation will be delivered with a shame model of the same device that used in the taVNS intervention. The interference of the device will display that the device is working normally while no electrical current output.

sham-taVNS + TENS

transcutaneous electrical nerve stimulation DEVICE

TENS will be delivered with commercial TENS machine. The stimulation parameters were as follows: continuous 0.2-ms square pulses at 100 Hz with the intensity adjusted according to the tolerance of each patient. Disposable surface electrodes of 5X5 cm2 were applied to stimulate the median nerve and the superficial radial nerve of both the affected and non-affected upper limbs. The placebo stimulation was delivered with a device that looked identical but had its internal electrical circuit disconnected.

sham-taVNS + TENS; taVNS + TENS

sham transcutaneous electrical nerve stimulation DEVICE

The sham stimulation will be administered using a device that looks identical to the TENS device used in the TENS intervention. However, the internal electrical circuit of this device will be disconnected.

taVNS + sham-TENS

task-oriented training OTHER

A physiotherapist supervised the intervention and monitored individual progress. The task-oriented training aims to improve the motor recovery of the upper limbs through the systematic and repetitive movement of shoulder, elbow, forearm, wrist and fingers. The task-oriented training will be conducted in seating position with a table in front. Each training task will be repeated for 10 repetitions per set with 1 minute of rest between sets.The progressions are repositioning from gravity eliminate to against position, improve movement quality, increasing number of sets and shortening rest period.

control training group; sham-taVNS + TENS; taVNS + TENS; taVNS + sham-TENS

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 55 - 75 years old;
• diagnosed with stroke confirmed by magnetic resonance imaging or computed tomography for more than 6 months;
• had volitional control of the non-paretic arm and at least minimal antigravity movement in the paretic shoulder;
• had at least 5 degrees of wrist extension in the antigravity position;
• be able to communicate

You may not qualify if:

• had neurological disease other than stroke, e.g., Parkinson's disease or dementia;
• ongoing healthy condition, e.g., angina pectoris, pain, or arthritis;
• had any contraindications of taVNS (metal implants in the brain, history of seizure)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Kowloon, Hong Kong

RECRUITING

Related Publications (9)

• Liu, Ng, and Ng (2014) Translation and initial validation of the Chinese (Cantonese) version of community integration measure for use in patients with chronic stroke. Biomed Res Int 2014(1):623836.

  BACKGROUND

• Vellone, Savini, Fida, Dickson, Melkus, Carod-Artal, Rocco, and Alvaro (2015) Psychometric evaluation of the Stroke Impact Scale 3.0. J Cardiovasc Nurs 30(3):229-241.

  BACKGROUND

• Oleson and Marino (2014) Responsiveness and concurrent validity of the revised capabilities of upper extremity-questionnaire (CUE-Q) in patients with acute tetraplegia. Spinal Cord 52(8):625-628.

  BACKGROUND

• Marino, Kern, Leiby, Schmidt-Read, and Mulcahey (2015) Reliability and validity of the capabilities of upper extremity test (CUE-T) in subjects with chronic spinal cord injury. J Spinal Cord Med 38(4):498-504.

  BACKGROUND

• Uswatte, Taub, Morris, Light, and Thompson (2006) The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology 67(7):1189-1194.

  BACKGROUND

• Chen, Lai, Chung, and Ng (2017) The Jacket Test for assessing people with chronic stroke. Disabil Rehabil 39(25):2577-2583.

  BACKGROUND

• Wolf, Catlin, Ellis, Archer, Morgan, and Piacentino (2001) Assessing Wolf Motor Function Test as Outcome Measure for Research in Patients After Stroke. Stroke 32(7):1635-1639

  BACKGROUND

• Ren, Wong, Lai, and Ng (2025) Psychometric assessment of the translated and culturally adapted Chinese (Cantonese) of the brief memory and executive test in people with stroke. Eur J Phys Rehabil Med 61(3):401-410. https://doi.org/10.23736/S1973-9087.25.08873-2

  BACKGROUND

• Fugl-Meyer, Jaasko, Leyman, Olsson, and Steglind (1975) The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med 7(1):13-31.

  BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Shamay Ng, Professor

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shamay NG, PhD

CONTACT

+852 27664889; shamay.ng@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 23, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)