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Subject Recruitment for the Clinical Research “Transcutaneous spinal cord electrical stimulation combined with Kunming Locomotor Training for the treatment of spinal cord injury”

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  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.

  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.

  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.

  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, and the "Hong Kong Spinal Cord Injury Foundation" provides research funding support.

  The study has been approved by the Ethics Committee of Kunming Tongren Hospital.

  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:


  Inclusion and exclusion criteria

  Inclusion Criteria

  Chronic (≧6 months) paraplegics (T1-T10) with incomplete(AIS B/C/D) spinal cord injury Incomplete aged 16-50 years;

  Subjects must be able to read, understand, and complete the Visual Analogue Scale;

  Subjects voluntarily sign the informed consent form approved by the ethics committee.

  *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.

  exclusion criteria

  Obvious renal, cardiovascular, hepatic, and mental diseases;

  Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;

  Limb contracture deformity;

  Modified Ashworth > Grade 2;

  Unhealed fractures;

  The subject is currently participating in other studies;

  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.


  Treatment Method

  Kunming Locomotor Training:

  Train for at least 1 hour per day, 5 hours per week, continuously for 6 months.

  Kunming Locomotor Training with Transcutaneous Spinal Cord Stimulation:

  Train for 1 hour per session, every other day, 3 times per week, continuously for 6 months.


  Treatment Period  6 months

  Costs for Participating in the study

  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.

  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.

  Outpatients: Outpatients do not need to pay hospitalization-related expenses. Examination fees incurred by the project research are self-paid.

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