Spinal Cord InjuriesNCT06802640
Transcutaneous Spinal Cord Electrical Stimulation Combined With Kunming Locomotor Training for the Treatment of Spinal Cord Injury
A study testing Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training in people with Spinal Cord Injuries, run by Kunming Tongren Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Combination Product: Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training |
| Group B | Sham comparator | Not described Receives: Combination Product: Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Kunming Locomotor Scale (KLS) at 6 months
Scale from minimum (1) to maximum (10), higher scales mean a better outcome.
Measured: 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.
Measured: Day 0, Month 6
Secondary outcomes (2)
Change from Baseline Spinal cord injury functional ambulation profile (SCI-FAP) at 6 months
Higher scores generally indicate greater independence and better walking ability.
Measured: Day 0, Month 6
Change from Lower extremity motor score(LEMS) at 6 months
a lower score indicates greater motor impairment in the lower extremities
Measured: Day 0, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion31 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunming Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Zhu, Kunming Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802640
- Sponsor's protocol ID
- KunmingTH_HZ_004
- Status last verified
- Jan 2025
- First submitted
- 26 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Spinal Cord Electrical Stimulation Combined With Kunming Locomotor Training for the Treatment of Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06802640
- Acronym / sponsor ID
- KunmingTH_HZ_004
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Kunming Tongren HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous spinal cord electrical stimulation and Kunming Locomotor TrainingPatients 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. | Combination product | Group A, Group B |
Primary outcome
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.
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous spinal cord electrical stimulation and Kunming Locomotor Training in people with Spinal Cord Injuries, run by Kunming Tongren Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Zhu, Bachelor (+8613888370040, kmzhuhui@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Kunming Locomotor Scale (KLS) at 6 months (time frame: Day 0, Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.