taVNS Combined With TENS on Motor Function in Stroke

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

Overview

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

Interventions

• Device transcutaneous auricular vagus nerve stimulation
  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
• Device sham transcutaneous auricular vagus nerve stimulation
  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.
• Device transcutaneous electrical nerve stimulation
  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 disconn
• Device sham transcutaneous electrical nerve stimulation
  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.
• Other task-oriented training
  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

Primary outcome measures

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

Secondary outcome measures (8)

• Jacket test [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).]
• Motor Activity Log (MAL) [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).]
• Capabilities of upper extremity test (CUE-T) [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).]
• Hand grip strength [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).]
• Pinch grip strength [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).]
• Capabilities of upper extremity-questionnaire (CUE-Q) [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).]
• Stroke impact scale (SIS) [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).]
• Community integration measure(CIM) [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).]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• The Hong Kong Polytechnic University — Kowloon

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 40358471

Identifiers

NCT: NCT07425756 · 25-VNS-GRF-LJ

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗