Effect of Specific mode electroacupuncture stimulation combined with NGF during the ischaemic stroke: Study protocol for a randomized controlled trial

• Published in: Clinics (São Paulo, Brazil) Brazil), 2024-01, Vol.79, p.100451, Article 100451
• Main Authors: Dai, Mengyuan, Zhao, Yibin, Jia, Zhaoxing, Xu, Shiting, Xu, Nuo, Wu, Xuewen, Liu, Jianxun, Wu, Lixiu, Yu, Kunqiang, Lin, Xianming
• Format: Article
• Language: English
• Subjects: Adult; Combined Modality Therapy; Electroacupuncture; Electroacupuncture - methods; Female; Humans; Ischemic stroke; Ischemic Stroke - therapy; Male; MEDICINE, GENERAL & INTERNAL; Middle Aged; Nerve Growth Factor; NGF; Original; Randomized Controlled Trials as Topic; Study protocol; Treatment Outcome
• ISSN: 1807-5932; 1980-5322; 1980-5322
• DOI: 10.1016/j.clinsp.2024.100451

•This protocol describes a multicentre, randomized, placebo-controlled trial that aims to assess the efficacy and safety of specific stimulation mode SMES combined with NGF in reducing the recovery period of ischaemic stroke and provide evidence-based medical data.•This research will help provide the latest and high-quality evidence for clinicians and policymakers seeking innovative and effective ways to treat patients with ischaemic stroke. The 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. A 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. This study will provide clinical evidence for the efficacy and safety of SMES combined with NGF in the treatment of stroke patients.