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StrokeNCT07425756

taVNS Combined With TENS on Motor Function in Stroke

A study testing transcutaneous auricular vagus nerve stimulation, transcutaneous electrical nerve stimulation and task-oriented training in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 50 to 75 years
Conditions the study is for
Stroke
What is being tested?
transcutaneous auricular vagus nerve stimulation, transcutaneous electrical nerve stimulation and task-oriented training
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteHong Kong
Study dates
1 Jan 2025to 1 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hong Kong1 site, 1 recruiting
  • The Hong Kong Polytechnic University

    Kowloon

    Shamay Ng, PhD, +852 2766 4889, shamay.ng@polyu.edu.hk

    Shamay Ng, PhD

    Recruiting

Other trials in Hong Kong

About this study

Official title: Effect of Combining Transcutaneous Vagus Nerve Stimulation With Peripheral Nerve Stimulation on Upper Limb Motor Function in People With Stroke: A Single- Blinded Randomised Controlled Trial

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
Being tested
transcutaneous auricular vagus nerve stimulation, sham transcutaneous auricular vagus nerve stimulation, transcutaneous electrical nerve stimulation, sham transcutaneous electrical nerve stimulation, task-oriented training
Keywords
stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcutaneous auricular vagus nerve stimulationDevice

    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

  • sham transcutaneous auricular vagus nerve stimulationDevice

    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.

  • transcutaneous electrical nerve stimulationDevice

    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 transcutaneous electrical nerve stimulationDevice

    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.

  • task-oriented trainingOther

    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.

Study groups in NCT07425756
Study groupRoleWhat they receive
taVNS + TENSExperimentalparticipate will received taVNS cominged with TENS
Receives: Device: transcutaneous auricular vagus nerve stimulation; Device: transcutaneous electrical nerve stimulation; Other: task-oriented training
sham-taVNS + TENSSham comparatorparticipate will received sham-taVNS cominged with TENS
Receives: Device: sham transcutaneous auricular vagus nerve stimulation; Device: transcutaneous electrical nerve stimulation; Other: task-oriented training
taVNS + sham-TENSSham comparatorparticipate will received taVNS cominged with sham-TENS
Receives: Device: transcutaneous auricular vagus nerve stimulation; Device: sham transcutaneous electrical nerve stimulation; Other: task-oriented training
control training groupActive comparatorparticipate will receive exercise training only
Receives: Other: task-oriented training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: 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)
  1. Jacket test

    The jacket test will be used to assess the upper limb proficiency in putting on and removing a long-sleeved jacket. The participants will be required to put on a long-sleeved coat completely, so that it was straight on their shoulders, and then to remove it completely, while maintaining a standing position. The time taken to complete the task was recorded.

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

  2. Motor Activity Log (MAL)

    The motor activity log (MAL) will be used to assess the ADLs. The MAL has 30 items including object manipulation and upper limb gross activities. Each item is in both quality of movement and amount of movement on a 6-point Likert scale (0-5). The total scale ranges from 0 to 150 with higher score indicate better ADL.

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

  3. Capabilities of upper extremity test (CUE-T)

    The CUE-T will be used to assess the upper limb function capacity. It consists of 19 unilateral and bilateral upper limb tasks. Depending on the item, scoring is based on performance of the task, the number of repetitions of the task, or time to complete the task. Raw scores are converted to a 5-point scale (0-4). Total score ranges from 0 to 120 with higher score indicate greater functional capacity. Affected side or unaffected side scores can be obtained by adding the score of the unilateral items on each side

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

  4. Hand grip strength

    The K-Grip hand-hold dynamometer (K-Grip, kinvent biomecanique, Montpellier, France) will be used for hand grip measurement. The participants will be seated in a comfortable chair with arm support and elbow in 90° flexion. Participants will be asked to make a maximal effort for at least 5 s with verbal encouragement. There were three trials for both side and the average value will be used for statistical analysis.

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

  5. Pinch grip strength

    The electronic Jamar pinch gauge will be used to measure the later pinch grip strength. The participants will be seated in a comfortable chair with arm support and elbow in 90° flexion. Participants will be asked to make a maximal effort for at least 5 s with verbal encouragement. There will be three trials for both side and the average value will be used for statistical analysis.

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

  6. Capabilities of upper extremity-questionnaire (CUE-Q)

    The CUE-Q will be used to assess the self-prospective functional limitation. It consists of 32 for unilateral and bilateral upper limb use, addressing areas of reaching and lifting, pulling, and pushing, wrist actions, and hand and finger actions. The responses are given on a 5-point Likert scale representing self-perceived difficulty in performing the action. Total score ranges from 0 to 160 with higher score indicate lesser functional limitation.

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

  7. Stroke impact scale (SIS)

    The SIS will be used to assess the quality of life. The SIS comprises 59 items covers eight domains of quality of life and an extra question on stroke recovery. Each item is rated on a 5-point Likert scale in terms of the difficulty in completing each item. The summative scores are generated for each domain, ranging from 0 to 100.

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

  8. Community integration measure(CIM)

    The Chinese version of CIM will be used to assess individuals' perceptions of community integration. It is a 10-item questionnaire with each item rated on a 5-point Likert scale, yielding a total score that ranges from 10 to 50. Higher scores indicate a better degree of perceived community integration.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2026
  2. Study start1 Jan 2025
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07425756
Sponsor's protocol ID
25-VNS-GRF-LJ
Status last verified
Jan 2026
First submitted
6 Feb 2026
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data can be requested based on reasonable request

Publications

  • Liu TW, Ng SS, Ng GY. Translation and initial validation of the Chinese (Cantonese) version of community integration measure for use in patients with chronic stroke. Biomed Res Int. 2014;2014:623836. doi: 10.1155/2014/623836. Epub 2014 Jun 4.

    PubMed 24995317
  • Vellone E, Savini S, Fida R, Dickson VV, Melkus GD, Carod-Artal FJ, Rocco G, Alvaro R. Psychometric evaluation of the Stroke Impact Scale 3.0. J Cardiovasc Nurs. 2015 May-Jun;30(3):229-41. doi: 10.1097/JCN.0000000000000145.

    PubMed 24695074
  • Oleson CV, Marino RJ. Responsiveness and concurrent validity of the revised capabilities of upper extremity-questionnaire (CUE-Q) in patients with acute tetraplegia. Spinal Cord. 2014 Aug;52(8):625-8. doi: 10.1038/sc.2014.77. Epub 2014 Jun 3.

    PubMed 24891011
  • Marino RJ, Kern SB, Leiby B, Schmidt-Read M, Mulcahey MJ. Reliability and validity of the capabilities of upper extremity test (CUE-T) in subjects with chronic spinal cord injury. J Spinal Cord Med. 2015 Jul;38(4):498-504. doi: 10.1179/2045772314Y.0000000272. Epub 2014 Oct 9.

    PubMed 25297342
  • Uswatte G, Taub E, Morris D, Light K, Thompson PA. The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006 Oct 10;67(7):1189-94. doi: 10.1212/01.wnl.0000238164.90657.c2.

    PubMed 17030751
  • Chen P, Lai CKY, Chung RCK, Ng SSM. The Jacket Test for assessing people with chronic stroke. Disabil Rehabil. 2017 Dec;39(25):2577-2583. doi: 10.1080/09638288.2016.1236413. Epub 2016 Oct 28.

    PubMed 27793076
  • Wolf SL, Catlin PA, Ellis M, Archer AL, Morgan B, Piacentino A. Assessing Wolf motor function test as outcome measure for research in patients after stroke. Stroke. 2001 Jul;32(7):1635-9. doi: 10.1161/01.str.32.7.1635.

    PubMed 11441212
  • Ren L, Wong T, Lai C, Ng S. 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. 2025 Jun;61(3):401-410. doi: 10.23736/S1973-9087.25.08873-2. Epub 2025 May 13.

    PubMed 40358471
  • Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

    PubMed 1135616

Questions about this trial

What is this clinical trial studying?

A study testing transcutaneous auricular vagus nerve stimulation, transcutaneous electrical nerve stimulation and task-oriented training in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shamay NG, PhD (+852 27664889, shamay.ng@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer assessment of upper extremity (FMA-UE) (time frame: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07425756, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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