Transcutaneous Spinal Cord Electrical Stimulation Combined With Kunming Locomotor Training for the Treatment of Spinal Cord Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries. Basic parameters: 16 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Change from Baseline Kunming Locomotor Scale (KLS) at 6 months [Time frame: Day 0, Month 6]
- Change from Baseline 10 Meter Walk Test (10mWT) at 6 months [Time frame: Day 0, Month 6]
Secondary outcome measures (2)
- Change from Baseline Spinal cord injury functional ambulation profile (SCI-FAP) at 6 months [Time frame: Day 0, Month 6]
- Change from Lower extremity motor score(LEMS) at 6 months [Time frame: Day 0, Month 6]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06802640 · KunmingTH_HZ_004