脊髓損傷(spinal cord injury, SCI)是一種臨床常見的嚴重外傷性中樞神經(jīng)損傷，目前臨床上對于SCI的治療仍是一個世界性難題。

　　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.

　　據(jù)國外研究證實：“經(jīng)皮脊髓電刺激(Transcutaneous electrical spinal cord stimulation TSCS)”是一種有效作用于激活人體運動相關(guān)回路的非侵入性技術(shù)。該方法利用獨特的無痛刺激波形，通過放置在脊柱皮膚上的電極傳輸，并可能通過背根(Dorsal roots，DRs)傳播以激活脊髓神經(jīng)回路。該項研究的成果最近發(fā)表在《Nature Medicine》上，研究結(jié)果顯示，經(jīng)皮脊髓電刺激治療技術(shù)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：對慢性不完全性(AIS B/C/D)脊髓損傷患者實施為期6個月的佩戴“經(jīng)皮脊髓電刺激”進行“昆明步行訓練”，觀察兩者的協(xié)同作用，并評估該治療方法是否能提高患者的運動功能。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.

　　該臨床研究系 “云南省蘇國輝院士工作站”研究項目。 項目由蘇國輝院士主導，研究方案由美國邁阿密大學醫(yī)學院神經(jīng)外科系教授、邁阿密脊髓損傷項目負責人James D. Guest教授設(shè)計并指導，昆明同仁醫(yī)院脊柱脊髓科具體實施。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.

　　研究已獲昆明同仁醫(yī)院倫理委員會的批準。The study has been approved by the Ethics Committee of Kunming Tongren Hospital.

　　本項目是一項國際化的研究，現(xiàn)將面向全球招募滿足入選標準的脊髓損傷患者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、入選及排除標準Inclusion and exclusion criteria入選標準Inclusion Criteria

　　1. 16-50歲不完全性(AIS B/ C/D)慢性脊髓損傷患者(T1-T10, 受傷時間≧6個月);Chronic (≧6 months) paraplegics (T1-T10) with incomplete(AIS B/C/D) spinal cord injury Incomplete aged 16-50 years;

　　2. 受試者必須能夠閱讀、理解和完成視覺模擬量表;Subjects must be able to read, understand, and complete the Visual Analogue Scale;

　　3. 受試者自愿簽署倫理委員會批準的知情同意書。Subjects voluntarily sign the informed consent form approved by the ethics committee.

　　*如果受試者同意參與但由于身體原因無法簽署知情同意書，則應(yīng)由受試者口頭同意、受試者的至親代其簽署、并請一位參與了知情同意全過程的中立見證人同時簽署。*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.

　　排除標準　　exclusion criteria

　　1. 明顯的腎、心血管、肝和精神性疾病;Obvious renal, cardiovascular, hepatic, and mental diseases;

　　2. 懷孕或哺乳婦女，有懷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. 肢體攣縮畸形;Limb contracture deformity;

　　4. 肌張力Modified Ashworth >2級;Modified Ashworth > Grade 2;

　　5. 骨折未愈合;Unhealed fractures;

　　6. 受試者目前正參與其他研究;The subject is currently participating in other studies;

　　7. 研究者的意見認為受試者不符合研究方案和/或不適合參與本研究。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、治療方法Treatment Method患者在佩戴經(jīng)皮脊髓刺激儀的同時進行昆明步行訓練。每天至少訓練1小時，每周5小時，連續(xù)訓練6個月。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、研究治療周期Treatment Period 6個月 6 months

　　四、參加治療的相關(guān)費用 Costs for Participating in the study1.免費項目：試驗期間跟研究方案有關(guān)的經(jīng)皮脊髓刺激儀治療及昆明步行訓練免費。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. 自費項目：Self-paid Items

　　(1)住院患者：住院相關(guān)費用，包括：床位費、檢查費、診查費、護理費、與本研究不相關(guān)的其它疾病所產(chǎn)生的治療費或醫(yī)藥費，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)門診患者：無需支付住院相關(guān)費用。項目研究所發(fā)生的檢查費用需自行支付。Outpatients: Outpatients do not need to pay hospitalization-related expenses. Examination fees incurred by the project research are self-paid.

　　昆明同仁醫(yī)院脊柱脊髓科將于2025年2月14日開展項目篩查義診活動，屆時，蘇國輝院士及James D. Guest教授將親臨現(xiàn)場和脊柱脊髓科朱輝主任一起進行義診。如您符合本項目的招募條件且有意向參加該項研究，可留言預約報名。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.