• Mengyuan Dai, Yibin Zhao, Zhaoxing Jia, Shiting Xu, Nuo Xu, Xuewen Wu, Jianxun Liu, Lixiu Wu, Kunqiang Yu, and Xianming Lin.
• The Third Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, Zhejiang Province, China; Department of Rehabilitation, The Second People's Hospital of Lishui, LiShui, ZheJiang Province, China.
• Clinics (Sao Paulo). 2024 Jan 1; 79: 100451100451.

BackgroundThe emergence of the Nerve Growth Factor (NGF) has promoted the development of neuroprotective therapy; however, it has little effect on cerebral ischemia because of its poor Blood-Brain Barrier (BBB) permeability. Specific Mode Electroacupuncture Stimulation (SMES) can open BBB safely and effectively; however, it has shown inconclusive clinical effects and indirect clinical evidence in the recovery phase. Hence, the authors conducted a multicentre, randomized, placebo-controlled, assessor-blinded clinical trial to assess the effectiveness and safety of SMES combined with NGF treatment used during ischaemic stroke recovery.MethodsA total of 288 stroke patients from three hospitals will be recruited and randomly allocated to four groups: acupuncture + placebo, acupuncture + NGF, SMES + placebo, and SMES + NGF, in a 1:1:1:1 ratio. Assessment data will be collected at baseline, 2-weeks, and 4-weeks during the treatment period, as well as at the 4-week and 8-week follow-up after treatment completion. The primary outcome measure will be the basic cure rate. The secondary outcome measures include the simplified Modified Barthel Index, Timed Up and Go Test, Fugl-Meyer Assessment of Motor Function Score, Tinetti Performance Oriented Mobility Assessment, Montreal Cognitive Assessment, and Loewenstein Occupational Therapy Cognitive Assessment. Moreover, resting-state functional magnetic resonance imaging and Functional near-infrared spectroscopy can detect changes in cerebral blood flow and brain function and investigate the relationship between the clinical efficacy and mechanism of the prescribed interventions.ConclusionThis study will provide clinical evidence for the efficacy and safety of SMES combined with NGF in the treatment of stroke patients.Copyright © 2024 HCFMUSP. Published by Elsevier España, S.L.U. All rights reserved.

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