NCT06802640

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Feb 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Feb 2025Dec 2027

First Submitted

Initial submission to the registry

January 26, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

2.7 years

First QC Date

January 26, 2025

Last Update Submit

January 26, 2025

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

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

    Day 0, Month 6

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

    Day 0, Month 6

Other Outcomes (1)

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

    Day 0, Month 6

Study Arms (2)

Group A

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

Group B

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

Interventions

Transcutaneous spinal cord electrical stimulation and Kunming Locomotor TrainingCOMBINATION_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 AGroup B

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \. Chronic (≧6 months) paraplegics (T1-T10) with incomplete(AIS B/C/D) spinal cord injury Incomplete aged 16-50 years;
  • Subjects must be able to read, understand, and complete the Visual Analogue Scale;
  • Subjects voluntarily sign the informed consent form approved by the ethics committee.

You may not qualify if:

  • \. Obvious renal, cardiovascular, hepatic, and mental diseases;
  • Pregnant or lactating women and women of childbearing age who are unwilling to use contraception;
  • \. Limb contracture deformity;
  • \. Modified Ashworth \> Grade 2;
  • \. Unhealed fractures;
  • \. The subject is currently participating in other studies;
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Hui Zhu, Bachelor

CONTACT

+8613888370040kmzhuhui@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 26, 2025

First Posted

January 31, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

October 31, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 31, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share