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

NCT ID: NCT06802640

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2027-12-01

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

Group Type: EXPERIMENTAL

Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training

Intervention Type: COMBINATION_PRODUCT

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.

Group B

Group Type: SHAM_COMPARATOR

Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kunming Tongren Hospital

INDUSTRY

Sponsor Role: lead

Responsible Party

Hui Zhu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hui Zhu, Bachelor

Role: CONTACT

kmzhuhui@sina.com

+8613888370040

Other Identifiers

KunmingTH_HZ_004

Identifier Type: -

Identifier Source: org_study_id