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NCT Number: NCT06802640

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training

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.

Primary outcomes

  1. Change from Baseline Kunming Locomotor Scale (KLS) at 6 months

    Time frame: Day 0, Month 6

    Scale from minimum (1) to maximum (10), higher scales mean a better outcome.

  2. Change from Baseline 10 Meter Walk Test (10mWT) at 6 months

    Time frame: 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 outcomes

  1. Change from Baseline Spinal cord injury functional ambulation profile (SCI-FAP) at 6 months

    Time frame: Day 0, Month 6

    Higher scores generally indicate greater independence and better walking ability.

  2. Change from Lower extremity motor score(LEMS) at 6 months

    Time frame: Day 0, Month 6

    a lower score indicates greater motor impairment in the lower extremities

Other outcomes

  1. Change from Walking Index for Spinal Cord Injury (WISCI) at 6 months

    Time frame: Day 0, Month 6

    Higher scores generally indicate greater independence.

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Zhu, Bachelor

CONTACT

[email protected]

+8613888370040

Sponsors and collaborators

Lead sponsor

Kunming Tongren Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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