tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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

Primary outcome measure(s)

• Walking Index for Spinal Cord Injury, WISCI Ⅱ — Baseline、Week 1 of Stimulation and Completion of experiment
  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.
• 10-Meter Walk Test, 10MWT — Baseline、Week 1 of Stimulation and Completion of experiment
  Walking speed test: measures the time required for patients to walk 10 meters, used to assess their short-distance walking ability.
• Weight Bearing Capacity, WBC — Baseline、Week 1 of Stimulation and Completion of experiment
  It is a crucial outcome that requires monitoring, especially for patients with severe motor disorders who are unable to walk independently.

Trial sites (1)

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