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

Kunming Tongren Hospital

Status: Not yet enrolling

Conditions: Spinal Cord Injuries

Treatments: Combination Product: Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training

Study type: Interventional

Funder types: Industry

Identifiers

NCT06802640

KunmingTH_HZ_004

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Group A

Experimental group

Treatment:

Combination Product: Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training

Group B

Sham Comparator group

Treatment:

Combination Product: Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training