Effects of transcutaneous electrical nerve stimulation on cognitive function and upper limb motor function in people with chronic stroke: a study protocol for a randomised controlled trial

INTRODUCTION: Cognitive impairment and upper limb impairment are common complications following stroke, but rehabilitation interventions targeting post-stroke cognitive and upper limb motor deficits remain understudied. Transcutaneous electrical nerve stimulation, including transcutaneous vagus nerve stimulation (tVNS) and transcutaneous spinal cord stimulation (tSCS), can potentially alleviate cognitive impairment and promote motor recovery. Although tVNS and tSCS may facilitate neuroplasticity following stroke, their effects on cognitive and upper limb motor outcomes have not been sufficiently studied. Therefore, the proposed clinical trial will investigate the effects of tVNS and tSCS on cognitive function and upper limb motor function in people with chronic stroke. METHODS AND ANALYSIS: A three-arm sham-controlled single-blind parallel-group randomised controlled trial will be performed with people with chronic stroke. All participants (n=90) will be randomly allocated to receive 18 sessions of intervention with different stimulation protocols (tVNS, tSCS and sham stimulation) at a 1:1:1 ratio. All participants will receive upper limb exercises concurrent with the corresponding stimulation protocols for 45 min in each session, three sessions per week, for 6 weeks. The primary outcomes will be the Montreal Cognitive Assessment and Fugl-Meyer Assessment for Upper Extremity. The secondary outcomes will be the Rivermead Behavioural Memory Test, Digit Span Test, Trail Making Test, Wolf Motor Function Test, maximum isometric voluntary contraction of the elbow, muscle stiffness of the elbow extensor and flexor, Arm Activity Measure, Oxford Participation and Activity Questionnaire and 12-item Short-Form Survey. All outcomes will be assessed at baseline, after 9 and 18 sessions of the intervention, and 1 month after the cessation of the intervention. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Human Subjects Ethics Committee of The Hong Kong Polytechnic University (HSEARS20221011002). The results yielded from this study will be submitted for publication in peer-reviewed journals and at international conferences. TRIAL REGISTRATION NUMBER: NCT05615610.