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tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI

tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI

Recruiting
18-60 years
All
Phase N/A

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Overview

This clinical trial aims to evaluate the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) combined with rehabilitation training for treating paraplegia after spinal cord injury (SCI). Previous studies have shown that applying tSCS in the thoracolumbar region can enable patients with complete and incomplete SCI to immediately restore partial voluntary movement, but there are currently no domestic reports on the treatment of SCI paraplegia using tSCS combined with rehabilitation training. The main questions this study aims to answer include: 1. Compared with using tSCS alone, does combined rehabilitation therapy enable patients to better restore voluntary movement? 2. Will this treatment protocol result in fewer adverse events? 3. Can the tSCS combined with rehabilitation training protocol be applied to a large number of patients with paraplegia after SCI to help them restore voluntary movement?For paraplegic patients with SCI (spinal cord injury) whose injury duration exceeds 1 week, baseline data (pre-stimulation, at the end of the first week of stimulation, and post-experiment) need to be collected after assessment. After adjusting the stimulation parameters of tSCS (transcutaneous spinal cord stimulation) and modifying the rehabilitation training plan, a one-month personalized rehabilitation training program will be conducted, followed by at least four weeks of follow-up. Researchers will compare the assessment results recorded at different stages and use specific indicators to evaluate the safety and effectiveness of this treatment protocol.

Eligibility

Inclusion Criteria:

  • Age between 18 and 60 years old;
  • Spinal cord injury classified as AIS Grade A, B, C, or D, with the distance between the injury level and the conus medullaris at least 60mm
  • Able to cooperate with rehabilitation training;
  • Stable and healthy physiological condition, as determined by the researcher; must be able to complete the entire study period and cooperate with rehabilitation training.

Exclusion Criteria:

  • 1\. Obvious mental disorders (anxiety, depression, etc.) resulting in inability to complete relevant subjective assessments2. Presence of mental or cognitive impairments preventing participation in transcutaneous spinal electrical stimulation and follow-up3. Severe autonomic reflex disorders4. Severe muscle atrophy or joint contractures5. Life expectancy less than 1 year6. Progressive spinal instability or severe spinal deformities7. Uncontrolled hypertension, severe heart disease, or serious medical/respiratory conditions8. Severe hydronephrosis or renal dysfunction9. Individuals considered unsuitable by the researcher

Study details
    Spinal Cord Injury
    Paraplegia
    Spinal

NCT07907952

Beijing Tsinghua Chang Gung Hospital

31 October 2026

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