脊髓损伤(spinal cord injury, SCI)是一种临床常见的严重外伤性中枢神经损伤，目前临床上对于SCI的治疗仍是一个世界性难题。

　　Spinal cord injury (SCI) is a common and severe traumatic central nervous system injury in clinical practice. Currently, the treatment of SCI remains a worldwide challenge.

　　据国外研究证实：“经皮脊髓电刺激(Transcutaneous electrical spinal cord stimulation TSCS)”是一种有效作用于激活人体运动相关回路的非侵入性技术。该方法利用独特的无痛刺激波形，通过放置在脊柱皮肤上的电极传输，并可能通过背根(Dorsal roots，DRs)传播以激活脊髓神经回路。该项研究的成果最近发表在《Nature Medicine》上，研究结果显示，经皮脊髓电刺激治疗技术是安全且有一定效果的。

　　International studies have confirmed that TSCS is an effective non-invasive technique to activate the body's movement-related circuits. This method utilizes a unique stimulation waveform that is transmitted through electrodes placed on the skin of the spine and spreads through the dorsal roots (DRs) to activate the spinal cord neural circuits. The related study was recently published in the journal "Nature Medicine", showing that the transcutaneous spinal cord electrical stimulation treatment technology is safe and has certain effects.

　　本研究的主要目的是：对慢性不完全性(AIS B/C/D)脊髓损伤患者实施为期6个月的佩戴“经皮脊髓电刺激”进行“昆明步行训练”，观察两者的协同作用，并评估该治疗方法是否能提高患者的运动功能。The main objective of this study is to have patients with chronic incomplete (AIS B/C/D) spinal cord injuries wear "transcutaneous spinal cord electrical stimulator " and undergo "Kunming locomotor training" for 6 months, observe the synergistic effects of the two, and evaluate whether this treatment method can improve patients' motor functions.

　　该临床研究系 “云南省苏国辉院士工作站”研究项目。 项目由苏国辉院士主导，研究方案由美国迈阿密大学医学院神经外科系教授、迈阿密脊髓损伤项目负责人James D. Guest教授设计并指导，昆明同仁医院脊柱脊髓科具体实施。This clinical study is a research project of the "Yunnan Academician Kwok-Fai So Workstation". The project is led by Academician Kwok-Fai So, and the research protocol is designed and guided by Professor James D. Guest, a professor of Neurological Surgery at the University of Miami and The Miami Project to Cure Paralysis.The project will be specifically implemented by the Department of Spine and Spinal Cord Injury of Kunming Tongren Hospital.

　　研究已获昆明同仁医院伦理委员会的批准。The study has been approved by the Ethics Committee of Kunming Tongren Hospital.

　　本项目是一项国际化的研究，现将面向全球招募满足入选标准的脊髓损伤患者18名。招募事宜告知如下：This is an international study that will recruit 18 spinal cord injury patients from around the world who meet the criteria. The recruitment details are as follows:

　　一、入选及排除标准Inclusion and exclusion criteria入选标准Inclusion Criteria

　　1. 16-50岁不完全性(AIS B/ C/D)慢性脊髓损伤患者(T1-T10, 受伤时间≧6个月);Chronic (≧6 months) paraplegics (T1-T10) with incomplete(AIS B/C/D) spinal cord injury Incomplete aged 16-50 years;

　　2. 受试者必须能够阅读、理解和完成视觉模拟量表;Subjects must be able to read, understand, and complete the Visual Analogue Scale;

　　3. 受试者自愿签署伦理委员会批准的知情同意书。Subjects voluntarily sign the informed consent form approved by the ethics committee.

　　*如果受试者同意参与但由于身体原因无法签署知情同意书，则应由受试者口头同意、受试者的至亲代其签署、并请一位参与了知情同意全过程的中立见证人同时签署。*If the subject agrees to participate but is unable to sign the informed consent form due to physical reasons, the subject should give oral consent, the subject's immediate family member should sign on behalf of the subject, and a neutral witness who participates in the entire process of informed consent should also sign simultaneously.

　　排除标准　　exclusion criteria

　　1. 明显的肾、心血管、肝和精神性疾病;Obvious renal, cardiovascular, hepatic, and mental diseases;

　　2. 怀孕或哺乳妇女，有怀孕能力又不愿意避孕的女性;Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;

　　3. 肢体挛缩畸形;Limb contracture deformity;

　　4. 肌张力Modified Ashworth >2级;Modified Ashworth > Grade 2;

　　5. 骨折未愈合;Unhealed fractures;

　　6. 受试者目前正参与其他研究;The subject is currently participating in other studies;

　　7. 研究者的意见认为受试者不符合研究方案和/或不适合参与本研究。The researcher's opinion is that the subject does not comply with the research protocol and/or is not suitable to participate in this study.

　　二、治疗方法Treatment Method患者在佩戴经皮脊髓刺激仪的同时进行昆明步行训练。每天至少训练1小时，每周5小时，连续训练6个月。Patients will undergo Kunming Locomotor Training along with transcutaneous spinal cord stimulation. The training should be at least 1 hour per day, 5 hours per week, for 6 consecutive months.

　　三、研究治疗周期Treatment Period 6个月 6 months

　　四、参加治疗的相关费用 Costs for Participating in the study1.免费项目：试验期间跟研究方案有关的经皮脊髓刺激仪治疗及昆明步行训练免费。Free Items: During the trial period, treatments related to the research protocol, including transcutaneous spinal cord stimulation treatment and Kunming locomotor training, are free of charge. 2. 自费项目：Self-paid Items

　　(1)住院患者：住院相关费用，包括：床位费、检查费、诊查费、护理费、与本研究不相关的其它疾病所产生的治疗费或医药费，患者需自行支付。Inpatients: Inpatients need to pay for hospitalization-related expenses themselves, including bed fees, examination fees, consultation fees, nursing fees, and treatment fees or medical expenses for other diseases unrelated to this study. (2)门诊患者：无需支付住院相关费用。项目研究所发生的检查费用需自行支付。Outpatients: Outpatients do not need to pay hospitalization-related expenses. Examination fees incurred by the project research are self-paid.

　　昆明同仁医院脊柱脊髓科将于2025年2月14日开展项目筛查义诊活动，届时，苏国辉院士及James D. Guest教授将亲临现场和脊柱脊髓科朱辉主任一起进行义诊。如您符合本项目的招募条件且有意向参加该项研究，可留言预约报名。The Spine and Spinal Cord Injury Department of our hospital will hold a project screening clinic on February 14, 2025. At that time, Academician Kwok-Fai So and Professor James D. Guest will visit the site and screen patients together with Director Zhu Hui of the Spine and Spinal Cord Injury Department. If you meet the recruitment criteria and are interested in participating in the research, you can leave a message to make an appointment for registration.