An interventional study of Transcutaneous Spinal Cord Stimulation Combined with Rehabilitation Training in Spinal Cord Injury and Paraplegia, Spinal, sponsored by Beijing Tsinghua Chang Gung Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Beijing Tsinghua Chang Gung Hospital · Not applicable, Interventional, and Treatment
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 10 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Beijing Tsinghua Chang Gung Hospital is the lead sponsor of 108 studies on the registry; 56 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Transcutaneous Spinal Cord Stimulation Combined with Rehabilitation Training
For paraplegic patients with SCI (spinal cord injury) whose injury duration exceeds 1 week, baseline data (pre-stimulation, at the end of week 1 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.
Walking Index for Spinal Cord Injury, WISCI Ⅱ
The commonly used ordinal scale in clinical trials to measure walking ability in patients with spinal cord injury. Based on the severity of walking impairment, the walking function is divided into 21 levels (from level 0, where patients cannot stand or walk, to level 20, where patients can walk at least 10 meters without facilities or assistance) based on the equipment, braces, and assistance required for patients to walk 10 meters.
Time frame: Baseline、Week 1 of Stimulation and Completion of experiment
10-Meter Walk Test, 10MWT
Walking speed test: measures the time required for patients to walk 10 meters, used to assess their short-distance walking ability.
Time frame: Baseline、Week 1 of Stimulation and Completion of experiment
Weight Bearing Capacity, WBC
It is a crucial outcome that requires monitoring, especially for patients with severe motor disorders who are unable to walk independently.
Time frame: Baseline、Week 1 of Stimulation and Completion of experiment
Berg Balance Scale, BBS
Used for clinical assessment of balance function. The assessment includes 14 items, with each item scored from 0 to 4 points, resulting in a total score of 56 points. The scores are divided into three groups: 0-20, 21-40, and 41-56, which correspond to three activity states: wheelchair use, assisted walking, and independent walking. If the total score is less than 40 points, it indicates a risk of falling.
Time frame: Baseline、Week 1 of Stimulation and Completion of experiment
36-Item Short Form Health Survey，SF-36
Including 36 items divided into 8 dimensions: physiological function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. These dimensions belong to two major categories: physical health and mental health. The final score for each dimension ranges from 0 (lowest) to 100 (highest), with higher scores indicating better quality of life.
Time frame: Baseline、Week 1 of Stimulation and Completion of experiment
6-Min Walk Test, 6MWT
The walking speed test, which measures the distance a patient can walk in 6 minutes, reflects the overall functional status of the cardiorespiratory and musculoskeletal systems in daily activities.
Time frame: Baseline、Week 1 of Stimulation and Completion of experiment
Kinematic Assessment
The three-dimensional motion capture system is used to obtain kinematic records (gait temporal parameters, spatial parameters; hip, knee, and ankle joint angles) of patients during walking. The system's infrared cameras capture human kinematics by using infrared reflective markers placed on anatomical landmarks. High-definition cameras are used to capture patients' timing photographic images, which demonstrate the dynamics of patient movement through superimposed consecutive snapshots.
Time frame: Baseline、Week 1 of Stimulation and Completion of experiment
Plan to share: No
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