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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Combination product: Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hui Zhu, Bachelor; Phone Number: +8613888370040; Email: kmzhuhui@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Combination product: Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training; Patients will undergo Kunming Locomotor Training along with transcutaneous spinal cord stimulation. . The training is at least 1 hour per day, 5 hours per week, for 6 consecutive months.
Sham Comparator: Group B	Combination product: Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training; Patients will undergo Kunming Locomotor Training along with transcutaneous spinal cord stimulation. . The training is at least 1 hour per day, 5 hours per week, for 6 consecutive months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Kunming Locomotor Scale (KLS) at 6 months	Scale from minimum (1) to maximum (10), higher scales mean a better outcome.	Day 0, Month 6
Change from Baseline 10 Meter Walk Test (10mWT) at 6 months	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.	Day 0, Month 6

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Walking Index for Spinal Cord Injury (WISCI) at 6 months	Higher scores generally indicate greater independence.	Day 0, Month 6

Collaborators and Investigators

• Sponsor: Kunming Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 26, 2025
• First Submitted That Met QC Criteria: January 26, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 26, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: KunmingTH_HZ_004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No