Effects of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke

Официальное название

A Randomized Controlled Clinical Trial of Transcutaneous Electrical Nerve Stimulation on Cognitive Function and Upper Limb Motor Function in People With Chronic Stroke

Обзор

Upper limb impairment is present in more than 85% of people with stroke, which greatly affect the quality of life, social participation, and performance of daily activities of people with stroke. Previous study also revealed that 53.4% of people after stroke experienced cognitive impairment. Different cognitive domains might be affected following stroke, such as attention, memory, language, and orientation, and the problems with memory are often prominent. Yet, there is no effective treatment for the post-stroke cognitive impairment. Transcutaneous spinal cord stimulation (tSCS) and transcutaneous vagus nerve stimulation (tVNS) are simple and non-invasive treatment to improve upper limb motor function and cognitive function. However, no existing studies have explored on the effects of tSCS and tVNS on cognitive function in people with stroke. Therefore, the purpose of this study is to evaluate the effectiveness of transcutaneous electrical nerve stimulation (TENS) on improving upper limb function and cognitive function in people with chronic stroke.

Подробное описание

This study aims to investigate the effects of three intervention protocols in people with stroke. The participants in Group A will receive tSCS on C6 and T5 level of the spine with upper limb exercises. The participants in Group B will receive tVNS on the cymba conchae of left outer ear with upper limb exercises. The participants in Group C will receive placebo stimulation with upper limb exercises.

Вмешательства

• Устройство tSCS
  The participants in Group A will receive tSCS (Burst mode, 9 pulses per burst, pulse frequency = 160 Hz, burst frequency = 2 Hz) with upper limb exercises. The electrical stimulation will be generated by the neurostimulator (MH8000P; MEDIHIGHTEC MEDICAL CO., LTD., Taiwan). Two 7.5 × 12.6 cm electrodes will be attached between C6 and T5 level on each side of spinal column and with 2 cm from the spine. Intensity of TENS will be individually selected by the participants according to tolerance level
• Устройство tVNS
  The participants in Group B will receive tVNS (pulse frequency = 25Hz, pulse duration = 0.3 ms) on the cymba conchae of left outer ear with upper limb exercises.The electrical stimulation will be generated by the neurostimulator (MH8000P; MEDIHIGHTEC MEDICAL CO., LTD., Taiwan). Intensity of tVNS will be individually selected by the participants according to tolerance levels. Previous studies showed that it was effective to improve the upper limb motor function in people with stroke and cognitive
• Устройство Control
  The participants in Group C will receive placebo tSCS and tVNS with upper limb exercises, where the stimulation will be delivered by placebo-TENS device with disconnected electrical circuit.

Первичные конечные точки

• Fugl-Meyer Assessment of the Upper Extremity [Срок оценки: Baseline (0 week)]
• Fugl-Meyer Assessment of the Upper Extremity [Срок оценки: Mid-intervention (3 week)]
• Fugl-Meyer Assessment of the Upper Extremity [Срок оценки: Post-intervention (6 week)]
• Fugl-Meyer Assessment of the Upper Extremity [Срок оценки: 1-month follow-up (10 week)]
• Montreal Cognitive Assessment [Срок оценки: Baseline (0 week)]
• Montreal Cognitive Assessment [Срок оценки: Mid-intervention (3 week)]
• Montreal Cognitive Assessment [Срок оценки: Post-intervention (6 week)]
• Montreal Cognitive Assessment [Срок оценки: 1-month follow-up (10 week)]

Вторичные конечные точки (12)

• Wolf Motor Function Test [Срок оценки: Baseline (0 week)]
• Wolf Motor Function Test [Срок оценки: Mid-intervention (3 week)]
• Wolf Motor Function Test [Срок оценки: Post-intervention (6 week)]
• Wolf Motor Function Test [Срок оценки: 1-month follow-up (10 week)]
• Muscle strength [Срок оценки: Baseline (0 week)]
• Digit Span Test [Срок оценки: 1-month follow-up (10 week)]
• Digit Span Test [Срок оценки: Post-intervention (6 week)]
• Digit Span Test [Срок оценки: Mid-intervention (3 week)]
• Digit Span Test [Срок оценки: Baseline (0 week)]
• Arm Activity Measure [Срок оценки: 1-month follow-up (10 week)]
• Arm Activity Measure [Срок оценки: Post-intervention (6 week)]
• Arm Activity Measure [Срок оценки: Mid-intervention (3 week)]

Критерии участия

Критерии включения

• aged between 50 and 80;
• have suffered from a single stroke at least 6 months;
• had volitional control of the non-paretic arm and at least minimal antigravity movement in the paretic shoulder;

Критерии исключения

• have cardiac pacemaker or cochlear implant;
• have other neurological diseases;
• are taking medication that may affect measured outcomes;
• have skin lesions, infection, or inflammation near selected position;
• are participating in other drug/treatment programs.

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 — Гонконг

Публикации

• Nakayama H, Jorgensen HS, Raaschou HO, Olsen TS. Recovery of upper extremity function in stroke patients: the Copenhagen Stroke Study. Arch Phys Med Rehabil. 1994 Apr;75(4):394-8. doi: 10.1016/0003-9993(94)90161-9. PMID 8172497
• Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5. PMID 21571152
• Nichols-Larsen DS, Clark PC, Zeringue A, Greenspan A, Blanton S. Factors influencing stroke survivors' quality of life during subacute recovery. Stroke. 2005 Jul;36(7):1480-4. doi: 10.1161/01.STR.0000170706.13595.4f. Epub 2005 Jun 9. PMID 15947263
• Desrosiers J, Noreau L, Rochette A, Bourbonnais D, Bravo G, Bourget A. Predictors of long-term participation after stroke. Disabil Rehabil. 2006 Feb 28;28(4):221-30. doi: 10.1080/09638280500158372. PMID 16467057
• Ingwersen T, Wolf S, Birke G, Schlemm E, Bartling C, Bender G, Meyer A, Nolte A, Ottes K, Pade O, Peller M, Steinmetz J, Gerloff C, Thomalla G. Long-term recovery of upper limb motor function and self-reported health: results from a multicenter observational study 1 year after discharge from rehabilitation. Neurol Res Pract. 2021 Dec 27;3(1):66. doi: 10.1186/s42466-021-00164-7. PMID 34955097
• Barbay M, Diouf M, Roussel M, Godefroy O; GRECOGVASC study group. Systematic Review and Meta-Analysis of Prevalence in Post-Stroke Neurocognitive Disorders in Hospital-Based Studies. Dement Geriatr Cogn Disord. 2018;46(5-6):322-334. doi: 10.1159/000492920. Epub 2018 Nov 30. PMID 30504699
• Al-Qazzaz NK, Ali SH, Ahmad SA, Islam S, Mohamad K. Cognitive impairment and memory dysfunction after a stroke diagnosis: a post-stroke memory assessment. Neuropsychiatr Dis Treat. 2014 Sep 9;10:1677-91. doi: 10.2147/NDT.S67184. eCollection 2014. PMID 25228808
• Sun JH, Tan L, Yu JT. Post-stroke cognitive impairment: epidemiology, mechanisms and management. Ann Transl Med. 2014 Aug;2(8):80. doi: 10.3978/j.issn.2305-5839.2014.08.05. PMID 25333055

Идентификаторы

NCT: NCT05615610 · 2022_TVNS_STROKE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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