Transcutaneous Spinal Cord Electrical Stimulation Combined With Kunming Locomotor Training for the Treatment of Spinal Cord Injury

Not Applicable

Not yet recruiting

• Conditions: Spinal Cord Injuries

• Registration Number: NCT06802640
• Lead Sponsor: Kunming Tongren Hospital

Brief Summary

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-26
• Study First Submitted QC: 2025-01-26
• Last Update Submitted: 2025-01-26
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Study Start: 2025-02-01
• Primary Completion: 2027-10-31
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• 1. Chronic (≧6 months) paraplegics (T1-T10) with incomplete(AIS B/C/D) spinal cord injury Incomplete aged 16-50 years;
• 2.Subjects must be able to read, understand, and complete the Visual Analogue Scale;
• 3.Subjects voluntarily sign the informed consent form approved by the ethics committee.

Exclusion Criteria

• 1. Obvious renal, cardiovascular, hepatic, and mental diseases;
• 2.Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
• 3. Limb contracture deformity;
• 4. Modified Ashworth > Grade 2;
• 5. Unhealed fractures;
• 6. The subject is currently participating in other studies;
• 7. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline Kunming Locomotor Scale (KLS) at 6 months	Day 0, Month 6	Scale from minimum (1) to maximum (10), higher scales mean a better outcome.
Change from Baseline 10 Meter Walk Test (10mWT) at 6 months	Day 0, Month 6	The primary measure obtained from the test is the walking speed, which is calculated by dividing the distance by the time taken to complete the walk.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Spinal cord injury functional ambulation profile (SCI-FAP) at 6 months	Day 0, Month 6	Higher scores generally indicate greater independence and better walking ability.
Change from Lower extremity motor score(LEMS) at 6 months	Day 0, Month 6	a lower score indicates greater motor impairment in the lower extremities