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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device 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
• Device 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
• Device 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.

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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;

Exclusion criteria

• 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.

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 — Hong Kong

Publications

• 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

Identifiers

NCT: NCT05615610 · 2022_TVNS_STROKE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗