taVNS Combined With TENS on Motor Function in Stroke

Официальное название

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

Обзор

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

Вмешательства

• Устройство 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
• Устройство 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.
• Устройство 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
• Устройство 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.
• Другое 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

Первичные конечные точки

• Fugl-Meyer assessment of upper extremity (FMA-UE) [Срок оценки: 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) [Срок оценки: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).]

Вторичные конечные точки (8)

• Jacket test [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (A0) , 3 weeks from baseline (A1), immediately after the interventions (A2), 4 weeks follow-up (A3) and 8 weeks follow-up (A4).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Kowloon

Публикации

• 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

Идентификаторы

NCT: NCT07425756 · 25-VNS-GRF-LJ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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